Feasibility Study Research Articles

Use of the FebriDx® host-response point-of-care test may reduce antibiotic use for respiratory tract infections in primary care: a mixed-methods feasibility study.

FebriDx® is a CE-marked, single-use point-of-care test with markers for bacterial [C-reactive protein (CRP)] and viral [myxovirus resistance protein A (MxA)] infection, using finger-prick blood samples. Results are available after 10-12 min. We explored the usability and potential impact of FebriDx® in reducing antibiotic prescriptions for lower respiratory tract infection (LRTI) in primary care, and the feasibility of conducting a randomized controlled trial (RCT). Patients (aged ≥1 year) with LRTI deemed likely to receive antibiotic prescription were recruited at nine general practices and underwent FebriDx® testing. Data collection included FebriDx® results, antibiotic prescribing plan (before and after testing) and re-consultation rates. Staff completed System Usability Scale questionnaires. From 31 January 2023 to 9 June 2023, 162 participants participated (median age 57 years), with a median symptom duration of 7 days (IQR 5-14). A valid FebriDx® result was obtained in 97% (157/162). Of 155 patients with available results, 103 (66%) had no detectable CRP or MxA, 28 (18%) had CRP only, 5 (3%) had MxA only, and 19 (12%) had both CRP and MxA. The clinicians' stated management plan was to prescribe antibiotics for 86% (134/155) before testing and 45% (69/155) after testing, meaning a 41% (95% CI: 31%, 51%) difference after testing, without evidence of increased re-consultation rates. Ease-of-use questionnaires showed 'good' user-friendliness. Use of FebriDx® to guide antibiotic prescribing for LRTI in primary care was associated with a substantial reduction in prescribing intentions. These results support a fully powered RCT to confirm its impact and safety.

Feasibility study for the development of multilayered solar cells for proton linear energy transfer depth profile measurement.

Previous study proposed a method to measure linear energy transfer (LET) at specific points using the quenching magnitude of thin film solar cells. This study was conducted to propose a more advanced method for measuring the LET distribution. This study focuses on evaluating the feasibility of estimating the proton LET distribution in proton therapy. The feasibility of measuring the proton LET and dose distribution simultaneously using a single-channel configuration comprising two solar cells with distinct quenching constants is investigated with the objective of paving the way for enhanced proton therapy dosimetry. Two solar cells with different quenching constants were used to estimate the proton LET distribution. Detector characteristics (e.g., dose linearity and dose-rate dependency) of the solar cells were evaluated to assess their suitability for dosimetry applications. First, using a reference beam condition, the quenching constants of the two solar cells were determined according to the modified Birks equation. The signal ratios of the two solar cells were then evaluated according to proton LET in relation to the estimated quenching constants. The proton LET distributions of six test beams were obtained by measuring the signal ratios of the two solar cells at each depth, and the ratios were evaluated by comparing them with those calculated by Monte Carlo simulation. The detector characterization of the two solar cells including dose linearity and dose-rate dependence affirmed their suitability for use in dosimetry applications. The maximum difference between the LET measured using the two solar cells and that calculated by Monte Carlo simulation was 2.34keV/µm. In the case of the dose distribution measured using the method proposed in this study, the maximum difference between range measured using the proposed method and that measured using a multilayered ionization chamber was 0.7mm. The expected accuracy of simultaneous LET and dose distribution measurement using the method proposed in this study were estimated to be 3.82%. The signal ratios of the two solar cells, which are related to quenching constants, demonstrated the feasibility of measuring LET and dose distribution simultaneously. The feasibility of measuring proton LET and dose distribution simultaneously using two solar cells with different quenching constants was demonstrated. Although the method proposed in this study was evaluated using a single channel by varying the measuring depth, the results suggest that the proton LET and dose distribution can be simultaneously measured if the detector is configured in a multichannel form. We believe that the results presented in this study provide the envisioned transition to a multichannel configuration, with the promise of substantially advancing proton therapy's accuracy and efficacy in cancer treatment.

Feasibility of Observing Cerebrovascular Disease Phenotypes with Smartphone Monitoring: Study Design Considerations for Real-World Studies.

Accelerated by the adoption of remote monitoring during the COVID-19 pandemic, interest in using digitally captured behavioral data to predict patient outcomes has grown; however, it is unclear how feasible digital phenotyping studies may be in patients with recent ischemic stroke or transient ischemic attack. In this perspective, we present participant feedback and relevant smartphone data metrics suggesting that digital phenotyping of post-stroke depression is feasible. Additionally, we proffer thoughtful considerations for designing feasible real-world study protocols tracking cerebrovascular dysfunction with smartphone sensors.

Aortic roadmapping during EVAR: a combined FEM-EM tracking feasibility study.

Currently, the intra-operative visualization of vessels during endovascular aneurysm repair (EVAR) relies on contrast-based imaging modalities. Moreover, traditional image fusion techniques lack a continuous and automatic update of the vessel configuration, which changes due to the insertion of stiff guidewires. The purpose of this work is to develop and evaluate a novel approach to improve image fusion, that takes into account the deformations, combining electromagnetic (EM) tracking technology and finite element modeling (FEM). To assess whether EM tracking can improve the prediction of the numerical simulations, a patient-specific model of abdominal aorta was segmented and manufactured. A database of simulations with different insertion angles was created. Then, an ad hoc sensorized tool with three embedded EM sensors was designed, enabling tracking of the sensors' positions during the insertion phase. Finally, the corresponding cone beam computed tomography (CBCT) images were acquired and processed to obtain the ground truth aortic deformations of the manufactured model. Among the simulations in the database, the one minimizing the in silico versus in vitro discrepancy in terms of sensors' positions gave the most accurate aortic displacement results. The proposed approach suggests that the EM tracking technology could be used not only to follow the tool, but also to minimize the error in the predicted aortic roadmap, thus paving the way for a safer EVAR navigation.

Application of ramie-based eco-friendly material in coastal protection structures in Indonesia: feasibility study focusing on strength and biodegradability

ABSTRACT Coastal erosion presents a significant environmental threat globally, including in the Northern Java coastal area of Indonesia. As employing hard structures is not an environmentally sustainable practice, nature-based solutions, such as mangrove forests, have emerged as a global trend offering sustainable coastal protection. However, safeguarding young seedlings from wave and current forces remains challenging. Given that temporary structures, such as synthetic geo-bag dikes, considered for protection pose environmental challenges as they degrade slowly, the use of natural fibres such as ramie, unique to Indonesia as a strategic raw commodity, is a sustainable alternative. The study examined ramie fibres (0.28 mm thick) as an eco-friendly geo-bag material through laboratory tests, biodegradability burial tests, and comparisons with other natural fibres. Despite alkali treatment, the strength of ramie fibre did not meet standard geotextile parameters, and its degradability rendered it unsuitable for the expected service life. Ramie would need specific treatments to become a viable alternative for geo-bags. In conclusion, further research is needed to explore how ramie can serve as a sustainable geo-bag material.

Self-conducted sonographic monitoring of the knee in patients with haemophilia-A feasibility study.

To evaluate whether patients with haemophilia (PwH) can be enabled to perform ultrasonography (US) of their knees without supervision according to the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol and whether they would be able to recognize pathologies. Five PwH (mean age 29.6 years, range 20-48 years) were taught the use of a portable US device and the HEAD-US protocol. Subsequently, the patients performed US unsupervised at home three times a week for a total of 6 weeks with a reteaching after 2 weeks. All images were checked for mapping of the landmarks defined in the HEAD-US protocol by a radiologist. In a final test after the completion of the self-sonography period, participants were asked to identify scanning plane and potential pathology from US images of other PwH. On the images of the self-performed scans, 82.7% of the possible anatomic landmarks could be identified and 67.5% of the requested images were unobjectionable, depicting 100% of the required landmarks. There was a highly significant improvement in image quality following reteaching after 2 weeks (74.80±36.88% vs. 88.31±19.87%, p<.001). In the final test, the participants identified the right scanning plane in 85.0% and they correctly identified pathology in 90.0% of images. Appropriately trained PwH can perform the HEAD-US protocol of their knee with high quality and are capable to identify pathologic findings on these standardized images. Asynchronous tele-sonography could enable early therapy adjustment and thereby possibly reduce costs.

Feasibility study utilizing a combinatorial functional precision medicine platform, Optim.AI, to help guide treatment for pancreatic cancer.

e13614 Background: Functional screening methods are increasingly applied to guide patient treatment and could be beneficial in indications with poor survival and response rates, such as pancreatic cancer. However, challenges faced when implementing ex vivo testing include complexities in obtaining sufficient tumor cells for different cancer types and maximizing the number of treatments tested with limited sample material. The latter is especially significant in informing clinical decision making as combination therapies are common with cancer, exponentially increasing the number of regimens to select from. To address this hurdle, we developed Optim.AI, a combinatorial functional precision medicine platform, which utilizes efficiently designed experiments and small data AI to expand to over 530,000 phenotypic response data points and predictively rank all actionable treatments within a 12-drug panel. In this feasibility study, we explored the application of Optim.AI on patient-derived tumor cells in pancreatic cancer. Methods: We established a procedure to run Optim.AI with isolated tumor cells from pancreatic cancer patients. After dissociation, these cells were then incubated to allow for 3D organoid formation within the following week. Upon organoid formation, the cells were treated with an FDA-approved panel of chemotherapy and targeted drugs. Cell viability was quantified post-drug treatment for analysis with Optim.AI software to rank all possible single to 4-drug combinatorial therapies for report generation. Results: The viability of the cells post-processing was high (mean = 97.4% live cells), passing the quality check of having at least 60% live cells before proceeding with Optim.AI testing. The success rate of organoid formation was 100% within 1 week of sample processing. The turnaround time from the receipt of samples to dissemination of the reports to clinicians was approximately a week (mean = 7.67 days). Z’ factor, a measurement of statistical effect size for high throughput screening, was demonstrated to be more than 0.5 for the reports generated, indicative of very good assays. The top ranked drug combinations were sensitive, with their normalized cell viability reported to be under 0.2, while the prior line of treatment was shown to be resistant, 100% concordant with previously observed clinical outcomes. Notably, Gemcitabine with either a HDAC or PI3K inhibitor was ranked high amongst the reports generated. Conclusions: Optim.AI had a high success rate in generating reports within a very short timeframe for pancreatic cancer. Comparing the top ranked therapies against the prior lines of treatment allows the clinicians to better evaluate the alternative treatments. Based on this initial feasibility study, Optim.AI could potentially be viable in guiding clinicians in managing treatment options for pancreatic cancer patients.

A multipurpose, adolescent idiopathic scoliosis-specific, short MRI protocol: A feasibility study in volunteers

IntroductionVisualization of scoliosis typically requires ionizing radiation (radiography and CT) to visualize bony anatomy. MRI is often additionally performed to screen for neural axis abnormalities. We propose a 14-minutes radiation-free scoliosis-specific MRI protocol, which combines MRI and MRI-based synthetic CT images to visualize soft and osseous structures in one examination. We assess the ability of the protocol to visualize landmarks needed to detect 3D patho-anatomical changes, screen for neural axis abnormalities, and perform surgical planning and navigation. Methods18 adult volunteers were scanned on 1.5 T MR-scanner using 3D T2-weighted and synthetic CT sequences. A predefined checklist of relevant landmarks was used for the parameter assessment by three readers. Parameters included Cobb angles, rotation, torsion, segmental height, area and centroids of Nucleus Pulposus and Intervertebral Disc. Precision, reliability and agreement between the readers measurements were evaluated. Results91 % of Likert-based questions scored ≥ 4, indicating moderate to high confidence. Precision of 3D dot positioning was 1.0 mm. Precision of angle measurement was 0.6° (ICC 0.98). Precision of vertebral and IVD height measurements was 0.4 mm (ICC 0.99). Precision of area measurement for NP was 8 mm2 (ICC 0.55) and for IVD 18 mm2 (ICC 0.62) for IVD. Precision of centroid measurement for NP was 1.3 mm (ICC 0.88–0.92) and for IVD 1.1 mm (ICC 0.88–91). ConclusionsThe proposed MRI protocol with synthetic CT reconstructions, has high precision, reliability and agreement between the readers for multiple scoliosis-specific measurements. It can be used to study scoliosis etiopathogenesis and to assess 3D spinal morphology.

A very-low-calorie diet (VLCD) intervention for the management of prediabetes and early Type 2 diabetes mellitus in a multi-ethnic cohort in Aotearoa New Zealand: The PROGRESS NZ feasibility study.

Very-low calorie diets (VLCD) achieve weight loss and remission of Type 2 diabetes (T2DM), but efficacy and acceptability in non-European populations is less clear. This feasibility study examines the impact of 10% weight loss through VLCD on metabolic and body composition outcomes in a multi-ethnic cohort of Aotearoa New Zealand (AoNZ) men with prediabetes/early T2DM, and VLCD tolerability/cultural acceptability. Participants followed a VLCD intervention (mean energy 3033kJ/day) until achievement of 10% weight loss. An oral glucose tolerance test (OGTT), hyperinsulinaemic isoglycaemic clamp with stable isotopes, hood calorimetry and dual-energy Xray absorptiometry (DXA) were undertaken before and after intervention. Qualitative data on VLCD tolerability/cultural acceptability were collected. Fifteen participants were enrolled; nine achieved 10% weight loss. In this group, mean HbA1c reduced by 4.8mmol/mol (2.4-7.1) and reverted to normoglycaemia in n=5/9; mean body weight reduced by 12.0 kg (11.0-13.1) and whole-body glucose disposal improved by 1.5 mg kgFFM-1 min-1 (0.7-2.2). Blood pressure and fasting triglycerides improved significantly. No changes in hepatic glu-cose metabolism were found. In all participants who attended completion testing, HbA1c reduced by 3.4mmol/mol (SD 3.5) and total weight by 9.0kg (SD 5.7). The intervention was highly tolerable/culturally acceptable however challenges with fulfilment of cultural obligations were described. Results support VLCD use in AoNZ however further work to investigate ethnic differences in physiological response to VLCDs and to optimise protocols for multi-ethnic populations are required.

Economic optimization of hybrid renewable energy resources for rural electrification

In rural areas, grid expansions and diesel generators are commonly used to provide electricity, but their high maintenance costs and CO2 emissions make renewable energy sources (RES) a more practical alternative. Traditional methods such as analytical, statistical, and numerical-based techniques are inadequate for designing an energy-efficient RES. Therefore, this study utilized the bat algorithm (BA) to optimize the use of hybrid RES for rural electrification. A feasibility study was conducted in the village of Kalema to assess energy consumption, and a diesel-only system was modeled to serve the entire community. The BA was used to determine the optimal size and cost-effectiveness of the hybrid RES, with MATLAB R (2021a) utilized for simulation. The BA's performance was compared with diesel only and GA using cost of energy (COE) and CO2 emissions as metrics. Diesel generators only produced a COE of $6,562,000 and 1679.6 lb/hr of CO2 emissions. COE with BA was $356,9781.37 (a 45.6% reduction) and CO2 emissions were 635.29 lb/hr (a 62.2% drop). Genetic algorithm (GA) resulted in $364,3122.46 COE and 652.69 lb/hr CO2 emissions, indicating 61.1% and 44.5% decreases, respectively. BA significantly reduced COE and CO2 emissions over GA, according to the analysis.

Mobile Health System for Meeting Health Information Needs in Patients With Head and Neck Cancer Undergoing Radiotherapy: Development and Feasibility Study.

Patients with head and neck cancer undergoing radiotherapy encounter physical and psychosocial challenges, indicating unmet needs. Mobile health technology can potentially support patients. This single-armed feasibility study included 30 patients with head and neck cancer undergoing radiotherapy. Patients were asked to use the Health Enjoy System, a mobile health support system that provides a disease-related resource for 1 week. We assessed the usability of the system and its limited efficacy in meeting patients' health information needs. The result showed that the system was well received by patients and effectively met their health information needs. They also reported free comments on the system's content, backend maintenance, and user engagement. This study supplies a foundation for further research to explore the potential benefits of the Health Enjoy System in supporting patients with head and neck cancer.

Clinical application of novel mobile AI solution for real-time detection and differential diagnosis in breast ultrasound: The first prospective feasibility study.

574 Background: Existing artificial intelligence (AI) solutions for breast ultrasound faced limitations due to their non-real-time detection and server dependency. However, novel mobile real-time AI solution now enable on-device detection and differential diagnosis, aiding in immediate decision-making. This study aims to evaluate the feasibility and effectiveness of such a mobile AI solution in clinical settings, by comparing it against expert breast imaging diagnoses. Methods: From August to December 2023, a feasibility study was conducted in tertiary medical center of Taiwan using mobile AI solution (CadAI-B for breast, BeamWorks Inc., Korea). CadAI-B is connected via HDMI or DVI to an ultrasound equipment using tablet PC. It supports healthcare providers to detect suspicious breast lesions by highlighting suspicious area during breast ultrasound scanning, and to make a differential diagnosis by providing BI-RADS categories and malignancy score (0-100%). The rate of real-time detection in malignancies and area under the receiver operating characteristic curve (AUC) was calculated. Distribution of BI-RADS categorized by CadAI-B were compared with those by breast imaging experts on independent review. Results: The analysis included 33 patients with an average age of 47 years (IQR, 44 – 62). There were 14 malignancies, 17 benign lesions, and 2 normal cases, and 30 patients (90.9%) underwent biopsy. For patients with malignancies, CadAI-B successfully identified all malignancies. Overall diagnostic performance, as AUCs calculated by the malignancy score and BI-RADS, was 0.835 and 0.850, respectively. The per-patient sensitivity of CadAI-B was 100.0%, while the specificity was 52.6%. The BI-RADS distribution between CadAI-B and expert was the same in malignant cases. In benign cases, CadAI-B categorized 9 cases (50.0%) as C4A or C4B, while experts classified 13 cases (72.2%), indicating a potential reduction in the need for biopsy. Conclusions: This study demonstrates that real-time processing capabilities of CadAI-B enable the identification of critical lesions during breast ultrasound, helping to reduce unnecessary biopsy. These findings may be helpful in diagnostic decisions and training of non-experts in clinical settings and offer the potential to improve workflow efficiency. [Table: see text]

The role of shared decision-making in cancer pain management: Insights from a systematic review.

e24078 Background: Effective pain management in cancer care is crucial for patient quality of life. Shared decision-making (SDM) interventions are increasingly recognized for their potential to improve patient outcomes by facilitating patient engagement in care decisions. This systematic review synthesizes evidence on the impact of SDM interventions in cancer pain management. Methods: This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We conducted a comprehensive search across multiple databases, including PubMed, EMBASE, Scopus, CINAHL, PsycINFO, Web of Science, and the Cochrane Library. The search also extended to grey literature sources such as conference proceedings, dissertations, and unpublished reports to ensure a thorough coverage of the subject matter. Our search strategy employed a combination of MeSH terms and keywords related to 'decision making,' 'patient participation,' 'pain management,' and 'cancer.' This strategy was tailored to each database's unique syntax and search operators. Results: Ten studies, including six pilot and feasibility studies and four randomized controlled trials (RCTs) and Preintervention-Postintervention studies, were systematically reviewed. The interventions implemented diverse SDM strategies ranging from digital tools and personalized education to clinical decision support systems, targeting key aspects of pain management and patient-provider communication. Frequent intervention components included patient-reported outcome dashboards, symptom management support, and educational resources for pain management. The Tailored Education and Coaching (TEC) intervention notably increased pain-specific patient communication by 31%, while the PAINRelieveIt intervention did not significantly impact analgesic adherence but effectively reduced pain misconceptions among caregivers. Some interventions, like the Carevive CPS, showed high patient involvement in SDM (94.1%) and compliance with quality oncology practice initiative metrics (98%). However, the effectiveness of these interventions varied, with some showing no significant impact on primary pain outcomes. The variability in measured outcomes such as pain intensity, analgesic adherence, and patient satisfaction indicates a context-dependent effectiveness of SDM interventions, highlighting the importance of personalized approaches and the role of implementation strategies in influencing patient engagement and intervention success. Conclusions: SDM interventions in cancer pain management are diverse in structure and impact. Some interventions show promise in improving communication and reducing misconceptions, but their direct effect on pain outcomes varies.

More Biosurfactants and Fewer Synthetic Surfactants to Improve Alkali-Surfactant-Polymer Flooding: Feasibility Study and Large-Scale Field Application

Summary Alkali-surfactant-polymer (ASP) flooding has achieved highly enhanced oil recovery (EOR) in the Daqing Oil Field; however, there are concerns about synthetic surfactants owing to their high cost and difficulty in biodegradation. Cheap biosurfactants conform to human concepts of green circular economy; however, known biosurfactants, as well as their mixtures with alkali, cannot reduce water/oil interfacial tension (IFT) to ultralow values below 0.01 mN/m, which is necessary for ASP flooding to effectively mobilize residual oil. Therefore, we investigate the feasibility of partially replacing synthetic surfactants with biosurfactants rather than completely replacing them to improve ASP flooding. First, through a series of IFT tests, a blend of rhamnolipids (RLs) and alkylbenzene sulfonate (ABS) in a 1:1 mass ratio is determined to be the optimal mixed surfactant and labeled RL/ABS-opt. Second, the interfacial activities, phase behaviors, and wettability alteration capabilities of ASP solutions with RL/ABS-opt are studied. Then, 1.0 wt% NaOH and 0.2 wt% RL/ABS-opt are determined to construct a new ASP system. Subsequently, the waterflooded cores are displaced using the new and the classical ASP systems. Based on the promising experimental results, the new ASP system floods a test block of 56 wells for 3 years. The EOR and surfactant costs are calculated to determine the technical and economic effects. Finally, the concentrations of surfactants before and after activated sludge treatment (AST) are tested by spectrophotometry to verify the biodegradability of RLs better than that of ABS. The laboratory and field results indicate that more biosurfactants and fewer synthetic surfactants could improve ASP flooding to be more environmentally friendly and cost-effective with a higher EOR.

Immune response to SARS-CoV-2 vaccine administered to patients with solid cancers under systemic treatment: A prospective, monocentric study (Immunocovid-19).

e23093 Background: Despite vaccination, COVID-19 could still cause severe disease in immunocompromised patients (pts). While subsequent vaccine doses increase immune response in the general population, few data concerning cancer pts under systemic treatment are reported. Methods: This study will be conducted on blood samples from 1000 pts admitted to Reggio Emilia AUSL-IRCCS Cancer Center and undergoing systemic therapies who received ≥ 2 vaccine doses. The samples will be analyzed at Clinical Microbiology and Chemistry Laboratories of Reggio Emilia AUSL-IRCCS. We will perform antibody IgM-IgG serology by means of COVID-19 VIRCLIA® Monotest and anti-spike antibodies evaluation using LIAISON® SARS CoV-2 Trimerics IgG. We will also investigate cell immune response (B and T lymphocyte counts) and analyze specific lymphocyte subsets on the first 200 pts treated with chemo- (CT) or immunotherapy (IO). Then, we will evaluate the T-cell response on the first 50 pts and those with an inadequate anti-spike serologic response through the T-SPOT.COVID test. Statistical analyses will be conducted by the Clinical Studies and Statistical Unit Staff. Results: Here, we report preliminary data on the first 240 pts enrolled and treated with CT (55.4%), IO (26.3%), or other therapies (18.3%). Most of the pts were male (58%), had metastatic cancer (82%), and no previous COVID-19 infection (60%). 84% of pts were affected by gastrointestinal, lung, urogenital and breast cancer. We stratified pts in three groups according to the time from the last vaccine dose (0-6/6-12/ &gt; 12 months). We showed no significant decrease in cellular and humoral immune response over time from the last vaccine dose, independent of the specific treatment received, also if CT (Table 1). Furthermore, clinical characteristics as gender, treatment, and primary tumor site appear not to influence immune response, even if a trend to a higher response in pts previously affected by COVID-19 has been observed. The T-SPOT.COVID test performed on the first 27 pts showed that 19% had no T-cell activation, even with good IgG response. Conclusions: This feasible and cost-effective study has a potential impact on public health. Although these are preliminary data, the immune response to COVID-19 vaccines remains good after 12 months from the last dose administered in cancer pts. The enrollment is ongoing, and we could provide relevant information on the influence of clinical factors on the immune response and identify specific subgroups that could benefit from different vaccine approaches. [Table: see text]

Usability and feasibility of the open-source GeRI platform for remote assessments in older adults with prostate cancer.

e13664 Background: The Geriatric Remote Initiative (GeRI) is an open-source tool to collect patient-generated health data for older adults with cancer. It comprises a WiFi-enabled Raspberry Pi tablet, a Bangle.js 2 wrist accelerometer, and Mi Body Composition Scale 2 for data collection. Following the initial phase where feedback from older cancer survivors and caregivers refined a demonstration GeRI platform, this study deployed a live version of GeRI in advanced prostate cancer patients to evaluate its feasibility and usability. Methods: In this single-arm pilot feasibility and usability study, we evaluated GeRI among ten advanced prostate cancer patients aged ≥65 years undergoing androgen deprivation (ADT) across varied frailty risk categories. Participants interacted with GeRI for ≥12 weeks. Data collection comprised demographics, clinical information, and vulnerability assessment (Cancer and Aging Research Group [CARG] score) from in-clinic surveys. Biometric (wearable/scale) and electronic patient-reported outcomes data from the tablet were securely transmitted to the institution’s HIPAA-compliant cloud. Usability was evaluated using the System Usability Scale (SUS), aiming for an average score of 68 or higher. Feasibility was achieved if ≥6 participants completed at least 50% of all prompted interactions with the system components (surveys, wearable, and weight/bioimpedance) throughout a 12-week study period. Results: Ten men with metastatic hormone-sensitive prostate cancer [median age: 73 years; 40% minority; median of 3 months of ADT exposure (IQR: 2-4.5); 80% had intensified ADT with 60% getting concurrent prostate-directed radiation] engaged with GeRI for a median of 104 days (IQR: 93-131). 40% were vulnerable with a CARG&gt;5. System usability, evaluated by SUS, yielded a mean score of 84 (SD: 12.5). All participants met the feasibility criterion. Deficiencies in obtaining complete 48-hour accelerometry data from 7 participants were noted with only 1 being due to persistent non-wear of the wearable and the remainder due to transmission failure. Conclusions: The GeRI platform exhibited exceptional usability and met all feasibility benchmarks in a geriatric oncology setting, highlighting its potential despite technical hurdles in accelerometry data collection. Further deployment of GeRI is underway [or planned] through an expanded program focusing on other cancer types, including head and neck, and more robust biometric data collection.

The Feasibilty of the Motor Control Home Ergonomics Elderlies' Prevention of Falls (McHeELP) Programme in Patients with Sarcopenia: A Pilot Study.

The objective of this pilot study was to investigate the feasibility of a three month 'Motor control Home ergonomics Elderlies' Prevention of falls' (McHeELP) programme on muscle mass, muscle strength, functionality, balance and fear of falling among older adults with sarcopenia. A feasibility study of the McHeELP programme was performed in patients with sarcopenia. Primary outcome measures included number of participants; number of participants that showed engagement with the programme; adherence rates; data loss in questionnaires and secondary outcome measures; any adverse events, related or not to the intervention programme. All participants received a home-based motor control exercise programme combined with an ergonomic home modification for 12 weeks. Secondary outcome measures included Hand Grip Strength, Bioimpendance Analysis, Muscle Mass, Functionality and Fear of Falling. Twelve participants, (74.9±5 years), completed the pilot study. Significant differences were recorded before and after the programme on participants' functionality (p < 0.001), balance (p < 0.05) and fear of falling (p < 0.001). The present study revealed that the McHeELP programme is fesasible and that it is possible to implement the programme in clinical practice. The McHeELP programme positively affects functionality, balance and fear of falling. Thus, it seems feasible to conduct a full-scale randomised controlled trial.

Feasibility study of a personalized tumor membrane vesicle vaccine immunotherapy for head and neck squamous cell carcinoma (HNSCC).

e14673 Background: Head and neck cancer exhibits a high degree of heterogeneity, with lack of common therapeutic targets. Our phase 1 clinical trial will evaluate a novel personalized immunotherapy approach using tumor membrane vesicles (TMV) prepared from the patients’ own surgically excised tumor tissue and modifying them by attaching GPI-B7-1 and GPI-IL-12 as immune boosting molecules. This personalized vaccine will then be administered to boost the tumor-specific immunity. We report here the feasibility of developing an effective personalized therapeutic cancer vaccine from surgically collected tumor tissue from patients with HNSCC. Methods: After obtaining informed consent, a total of 10 tumor specimens from 10 patients with HNSCC of various sites were collected (0.29-1.23 grams) and graded for cellularity by a pathologist. Tumor samples were then homogenized using sterile, disposable probes. The homogenate was ultracentrifuged over a sucrose gradient to enrich tumor membrane vesicles (TMV). Yield was evaluated by protein concentration and particle size was assessed by dynamic light scattering. TMV preparations were incorporated with GPI-B7-1 and GPI-IL-12 to generate the TMV vaccine using protein transfer, a spontaneous process. For the in vivo murine studies, TMV vaccine is prepared from murine oral cancer (MOC1) tumors and incorporated with murine GPI-B7-1 and GPI-IL-12. To investigate the protective anti-tumor immune response of TMV vaccine in combination with anti-PD1 antibody therapy, we used established murine oral cancer models. We administered two doses of TMV vaccine to naïve C57BL/6 mice and four doses of anti-PD-1 mAb. Mice were monitored for 21 months and then challenged with MOC1 tumor cells 1 week prior to euthanasia. Spleens were flash frozen in liquid nitrogen and stored in -80oC until RNA is isolated for RNA-seq analysis. Results: The yields of TMV were 2.5 – 5 mg per gram of tumor tissue from four human tumor samples. Further refinement of the TMV production process yielded up to 6 mg of TMV/gram of tumor tissue. All samples passed for incorporation of GPI-B7-1 and GPI-IL-12. GPI-B7-1 is able to bind to a natural ligand, CTLA-4 suggesting it is biologically active. All samples also demonstrated biologic activity for GPI-IL-12 as tested using a reporter cell line for IL-12 and displayed acceptable endotoxin levels in a range of 1-34 EU/mg TMV vaccine. The remaining 6 tumor samples are being processed. RNA-seq data from mouse model suggests that the TMV vaccine showed synergistic activity when combined with anti-PD1 antibody, with enhanced T cell responses. Conclusions: TMV vaccine production is feasible for a phase 1 clinical trial for patients whose resected tumor is at least 0.5 g in weight and 40% cellularity. Data in mice show that TMV vaccine synergizes with anti-PD1 in inducing tumor responses.

Comparison of lung aeration loss in open abdominal oncologic surgeries after ventilation with electrical impedance tomography-guided PEEP versus conventional PEEP: a pilot feasibility study.

Existing literature lacks high-quality evidence regarding the ideal intraoperative positive end-expiratory pressure (PEEP) to minimize postoperative pulmonary complications (PPCs). We hypothesized that applying individualized PEEP derived from electrical impedance tomography would reduce the severity of postoperative lung aeration loss, deterioration in oxygenation, and PPC incidence. A pilot feasibility study was conducted on 36 patients who underwent open abdominal oncologic surgery. The patients were randomized to receive individualized PEEP or conventional PEEP at 4 cmH2O. The primary outcome was the impact of individualized PEEP on changes in the modified lung ultrasound score (MLUS) derived from preoperative and postoperative lung ultrasonography. A higher MLUS indicated greater lung aeration loss. The secondary outcomes were the PaO2/FiO2 ratio and PPC incidence. A significant increase in the postoperative MLUS (12.0 ± 3.6 vs 7.9 ± 2.1, P < 0.001) and a significant difference between the postoperative and preoperative MLUS values (7.0 ± 3.3 vs 3.0 ± 1.6, P < 0.001) were found in the conventional PEEP group, indicating increased lung aeration loss. In the conventional PEEP group, the intraoperative PaO2/FiO2 ratios were significantly lower but not the postoperative ratios. The PPC incidence was not significantly different between the groups. Post-hoc analysis showed the increase in lung aeration loss and deterioration of intraoperative oxygenation correlated with the deviation from the individualized PEEP. Individualized PEEP appears to protect against lung aeration loss and intraoperative oxygenation deterioration. The advantage was greater in patients whose individualized PEEP deviated more from the conventional PEEP.

Pilot study of early integration of interventional pain management for patients with chronic cancer pain.

e24080 Background: Pain is a common, distressing, and costly complication of cancer. Treatment guidelines recommend consideration of interventional pain procedures in addition to pharmacotherapy, yet they are underutilized and often only considered for refractory pain despite high-dose opioids. We examined the feasibility of early integration of interventional pain management among ambulatory patients with chronic cancer pain. Methods: This single arm pilot feasibility study recruited patients from outpatient clinics at the Dana-Farber Cancer Institute. Eligible patients had metastatic or locally advanced solid tumors, persistent pain secondary to cancer/cancer treatment, average pain rating of 4 or higher (0-10 scale), and prognosis &gt; 6 months. Patients could not be taking more than 200 oral morphine equivalents per day. Patients were systematically referred to an interventional pain specialist for consideration of pain procedures, with monthly visits for 4 months. Measures of feasibility included the proportion of patients seen by the pain specialist within 4 weeks, and the proportion undergoing pain procedures. Patients completed surveys at baseline, 2 and 4 months; using the Consumer Assessment of Healthcare Providers and Systems (CAHPS), patients rated their satisfaction with pain clinic (range 0-10), and how often the pain doctor treated them with courtesy and respect, listened carefully, and explained things in a way they could understand (range 1-4, higher scores better). Among those undergoing procedures, patients indicated the percent pain relief they had from the procedure. Results: Between May 2022 and October 2023, 30 patients were enrolled (4 remain on study); mean age, 59.5, 50% male, with a variety of solid tumors; baseline “average pain” and “worst pain” scores were 4.3( SD,1.2) and 6.5( SD,1.6). All but one patient (96.7%) was seen in the pain clinic within four weeks; 57% (n = 17) received one or more pain procedure, with 20% (n = 6) undergoing repeat procedures. The most common procedures were neural blockade (8), celiac plexus neurolysis (n = 4), trigger point injection (n = 3), and epidural steroid injection (n = 3). Among patients receiving a procedure, the median percentage relief was 65% (IQR:30,80). Patients rated the quality of care from the pain clinic highly, with a mean score of 8.6( SD,1.6); and were satisfied with their pain physicians with a mean rating of 3.8( SD,0.4) on treating with respect, 3.7( SD,0.6) for listening, and 3.6( SD,0.6) for explaining. Conclusions: In this study of patients with cancer pain, systematic referral to interventional pain management specialists was feasible, and led to most patients receiving a pain procedure. Patients were satisfied with their pain care and reported meaningful relief of symptoms. Further study is needed to examine whether early integration of interventional pain management improves pain control. Clinical trial information: NCT05366413 .