Feasibility study using tissue as reagent for cancer therapy: endovascular ablation via thermochemistry

BackgroundPulsed electric field ablation (PFA) techniques for treating cardiac arrhythmias have attracted considerable interest. For example, atrial fibrillation can be effectively treated by pulmonary vein isolation using PFA. However, some arrhythmias originate deep within the myocardium, making them difficult to reach with conventional ablation methods. Therefore, this study aimed to explore endovascular catheter-based ablation using computational modeling to assess the electric field and temperature distributions during the procedure.MethodsA three-dimensional computer model of the ablation catheter and heart was developed. The catheter was positioned within the heart model to simulate endovascular ablation, and the ablation damage range was estimated using the 1000 V/cm contour. Additionally, a probe function was used to monitor the maximum electric field and temperature within the ablation zone to evaluate the feasibility and safety of this approach.ResultsThe electric field can penetrate blood vessels and fat to induce effective myocardial injury. The extent of myocardial damage increases with higher pulse voltages; however, excessive voltage may also damage blood vessels (vascular damage threshold: 3500 V/cm). An appropriate electrode configuration can achieve a more uniform myocardial injury across different cross-sections. Temperature rise near the catheter electrode is significant, but appropriate pulse interval settings can prevent thermal damage in the target area (simulated maximum temperature: 46.8 °C; thermal damage threshold for biological tissue: 55 °C).ConclusionIntravascular pulsed electric field ablation can effectively damage the myocardium without harming blood vessels when suitable pulse parameters are applied. The ablation device settings strongly influence the maximum temperature in the ablation zone and help limit thermal effects. These findings support the feasibility of using small endovascular catheters to treat cardiac arrhythmias.

Image-Guided Ablation in Breast Cancer Treatment

(1) Objective: To examine the efficiency and efficacy of using endovascular mapping and pulsed field ablation in the setting of a hybrid video-assisted thoracoscopic atrial fibrillation (AF) ablation procedure. (2) Methods: Eleven consecutive patients underwent hybrid video-assisted thoracoscopic epicardial ablation and left atrial appendage exclusion followed by endocardial ablation using pulsed field ablation energy. The completeness of epicardial and endocardial lesion sets were assessed using 3D electro-anatomical mapping. (3) Results: Left atrial appendage (LAA) exclusion and durable pulmonary vein isolation (PVI) and posterior wall isolation (PWI) were achieved in all patients. The endovascular part of the necessary lesion set using PFA energy was successful in 100% of the patients. All patients remained in SR during the 12-month follow-up period. (4) Conclusions: Our study confirms the feasibility of using endovascular pulsed field ablation to complete previously performed epicardial lesion sets during the hybrid AF ablation procedures, without extending the procedure time or increasing the risk of complications.

Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study

Prospective Evaluation of Dual-Energy Imaging in Patients Undergoing Image Guided Radiation Therapy for Lung Cancer: Initial Clinical Results

BackgroundA high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning.ObjectiveThis study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work.MethodsThe study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors.ResultsRecruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals.ConclusionsThis is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible.Trial RegistrationNetherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407International Registered Report Identifier (IRRID)DERR1-10.2196/22670

PurposeThe study was designed to evaluate the feasibility of a future full-scale randomized clinical trial (RCT) of the Alice Program, a body awareness therapy, based on the integrability of this approach into oncological rehabilitation, as well as the impact of the Alice Program on managing the adverse consequences of cancer and cancer therapy and improving the health literacy of breast cancer survivors.Materials/methodsWe conducted a single-arm, before-and-after feasibility study with pre- and post-treatment assessment of shoulder and trunk mobility, balance, and health-related quality of life, as well as a 5-year follow-up to assess patient experiences with the Alice Program. Feasibility outcomes included recruitment scope, adherence to the Alice Program, adverse events, and program structure. Twenty-nine women with breast cancer aged between 32 and 65 were included in the study. The Alice Program was conducted at the Rehabilitation Department of Uzsoki Hospital in Budapest.ResultsIneffective patient recruitment is the biggest obstacle to conducting a future RCT. Patients' experiences demonstrated the acceptability of the Alice Program, and the assessed variables indicated the effectiveness of the Alice Program in a small sample of breast cancer survivors.ConclusionsAlthough the findings suggest that it is feasible to conduct a future full-scale RCT of the Alice Program for breast cancer survivors, some changes are needed – for example to the recruitment strategy, selection criteria, and program structure – to optimise the time efficiency ratio.

To develop and test the feasibility of a tailored therapeutic educational program, with the aim of improving adherence to oral endocrine adjuvant chemotherapy in women with breast cancer. . A qualitative study to identify educational needs and a feasibility study assessing the efficacy of the program. . A comprehensive cancer center, the Lucien Neuwirth Cancer Institute in Saint-Priest-en-Jarez, France. . Two consecutive samples (N = 11, N = 6) of women taking adjuvant oral endocrine chemotherapy for breast cancer. . A mixed qualitative and quantitative method was used. The participants' representations of disease and treatment were explored through one-on-one interviews and then translated into educational needs, which were used to develop a tailored therapeutic education program. The pilot study evaluated the reach and efficacy using before-and-after comparisons. . Educational objectives, knowledge, trust in the treatment, and anxiety. . Five educational objectives (acquiring knowledge, improving communication skills, managing anxiety, managing side effects, and improving adherence) were identified through 11 interviews. A three-session program was developed. Eight of the 23 patients invited to participate in a pilot study accepted, and six completed the intervention. Knowledge improved from 38.9 of 100 preintervention to 69.4 of 100 postintervention (p = 0.045). Trust in treatment showed a trend to improvement from 5.5 of 10 to 8 of 10 (p = 0.14), but anxiety did not change significantly; anxiety went from 6 to 7 (p = 0.88). . Results from the feasibility study showed promising efficacy for the educational objectives and provided information about how the program could be improved. . Tailored educational programs conducted by trained nurses may help patients to adhere to and live with the effects of endocrine therapy.

First-line therapy for ovarian cancer with carboplatin followed by paclitaxel–gemcitabine (SCOTROC5): A feasibility study and comparative analysis of the SCOTROC series

PurposeUse of electronic patient-reported outcome (ePRO) tools in routine oncology practice can be challenging despite evidence showing they can improve survival, improve patient and practitioner satisfaction, and reduce medical resource utilization. Head and neck cancer (HNC) patients receiving radiation therapy (RT) may be a group that would particularly benefit from interventions focused on early symptom management.MethodsPatients undergoing definitive RT for HNC were enrolled in a feasibility study and received ePRO surveys integrated within the electronic medical record (EMR) on a weekly basis during RT. After completion of each ePRO survey, a radiation oncology registered nurse documented the findings and subsequent interventions within the EMR.ResultsThirty-four patients with HNC who received curative RT at a single center were enrolled. The total number of surveys completed was 194 with a median of 7 surveys per patient (range 1–8). There was a total of 887 individual abnormal findings reported on the ePROs, and the authors found that all 887 had a corresponding documented intervention. Post-treatment practitioner questionnaires highlighted that ePROs were felt to be helpful for the care team in providing care to HNC patients.ConclusionFor patients with HNC receiving RT, ePROs can be effectively utilized to address patient symptoms within an integrated health care system. Creating an infrastructure for the use of ePROs integrated within the EMR in routine care requires an approach that accounts for local workflows and buy-in from patients and the entire care team.

Background The mainstay of the therapy in breast cancer has been mastectomy or wide local excision along with axillary lymph node dissection (ALND). There are a lot of adverse effects associated with ALND, lymphedema being the most devastating. Sentinel lymph node biopsy (SLNB) can identify women who may or may not need axillary dissection and translate into a smaller number of patients undergoing axillary dissection. However, patients having positive lymph node on SLNB will still have to undergo ALND. To reduce the occurrence of lymphedema and its associated complications the technique of Axillary Reverse Mapping (ARM) has been developed. It is based on the hypothesis that the lymphatic pathway of the arm is not involved by the metastasis of the breast primary and after accurately identifying and preserving the arm lymphatics, there would be risk of neither lymphedema, nor leaving behind metastatic cells in the lymph nodes. This prospective study was carried out to evaluate the feasibility of ARM in patients undergoing ALND. Methods This prospective study was carried out in the Department of General Surgery, PGIMER, from July 2010 to Dec 2011. There were seventy five Biopsy/FNAC confirmed breast cancer female patients between 18 to 75 years. All patients were undergoing ALND as part of their treatment. Patients with any prior surgical treatment for primary invasive breast cancer, bilateral breast cancer and metastatic breast disease were excluded. Patients with heart diseases, active or uncontrolled infection, dementia, altered mental status or any psychiatric condition, pregnant or lactating women and with known allergies to blue dye were also excluded. All patients were treated as per the standard treatment for stage. All ALNDs were performed by a single surgeon. ARM was performed in all the patients by giving 5 ml of Isosulfan Blue Dye (Sterlized 1% solution) in the upper inner arm of the involved site approximately 60 minutes before exposure. Results The results were analyzed clinically during surgery and post-operatively by histo-pathological examination of lymphnodes. Intra-operatively, the identification of lymphnodes and lymphathics were noted in 17(22.7%) and 33 patients(44%) respectively. In none of the patient any attempt was made to preserve the blue nodes and all the lymph nodes were resected and sent for histopathological examination. In only 2 of 17 patients (11.76%) the lymph node was positive for malignant tumour cells. The tumour burden in both these patients was very high (more than 10 nodes involved). No association was found in the identification rates of ARM nodes and lymphatics to age, BMI, size of tumour, site of tumour, pathological status of axilla and timing of dye. Conclusion The identification rate of ARM lymphatics and nodes is low when only blue dye is used. The method appears it to be oncologically safe in patients with low tumour burden. However there is need for further studies will before this procedure can be universally applied without compromising the oncologic safety. Once the technique is proven to be oncologically safe even in a selected group of patients, a large randomized trial will be needed to give a satisfactory answer whether the problem of lymphedema be eliminated or minimized in the patients in whom arm lymphatics are successfully preserved. Citation Format: Khare S, Singh G, Das A, Bal A. Axillary reverse mapping: A feasibility study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P2-12-02.

Advanced epithelial ovarian cancer is associated with high relapse rates. Various consolidative therapies, including whole abdominal radiation therapy (WAR), have been tried in the past with limited success. We report here a feasibility study and clinical outcome of WAR with helical tomotherapy (HT). Eight patients with relapsed carcinoma ovary after standard treatment and deemed not suitable for further chemotherapy were treated with WAR using HT. All patients underwent intensity-modulated radiotherapy (IMRT) planning process and a dose of 25 Gy/25#, at 1 Gy/# to the whole of the abdomen [abdominal planning treatment volume (PTV)] with a simultaneous boost of 45 Gy/25#, at 1.8 Gy/# to the pelvic PTV was prescribed. There was an excellent coverage in both abdominal and pelvic PTVs.The V 95% (volume covered by the 95% isodose) and V 107% (volume receiving 107% dose) was 95.6 (± 2.7)% and 2.6 (± 0.5)% for abdominal PTV and 95.7 (± 2.4)% and 0% for pelvic PTV, respectively. With a median follow-up of 15 months (10-24 months, mean: 14 months), 3 patients developed disease recurrence. All 3 recurred in the peritoneum, one progressed to intestinal obstruction and fatal septicemia. WAR in recurrent/relapsed epithelial ovarian cancer is feasible with acceptable toxicities.

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CDK4/6 inhibitors as neoadjuvant treatment in breast cancer—what can we learn?

Background: LORIS is a multi-centre, randomised (1:1) controlled trial of Surgery v Active Monitoring with annual mammography in patients with low risk ductal carcinoma in situ (DCIS). During a 2 year Feasibility Study potential patients were invited to complete the Clinical Trials Questionnaire (CTQ)1 and participate in a semi structured telephone interview about the verbal, written and DVD based trial information. The DVD was produced to complement the patient information sheet (PIS) and incorporates simple graphics and a Q&A session with women asking the Chief Investigator questions about the trial. Aims:To examine the reasons for trial participation/rejection and obtain feedback about the clarity, timing and usefulness of the PIS and DVD in order to identify potential communication drivers and barriers to trial recruitment. Methods: Participants completed the CTQ1 prior to randomisation and with their consent were contacted following randomisation for an interview. Women declining the trial were issued with an optional pack containing the CTQ1 and the researchers' contact details if they wanted an interview. The CTQ1 comprises16 reasons that might influence a decision to either accept or decline a trial. For each statement participants register their agreement or disagreement on a scale of 1 (strongly agree) to 5 (strongly disagree) and indicate the most important reason for their decision. Interviews explored factors such as, attitudes about randomisation, and usefulness of the trial information provided. Results: 41 patients were randomised during feasibility; 20 surgery, 21 active monitoring, 16 patients declined the trial. 40/41(98%) acceptors and 9/16 (56%) decliners completed the CTQ1. The main reason for joining LORIS was:- “I thought the trial offered the best treatment available” 13/40 (32%) and for decling the trial was “The idea of randomisation worried me” (4/9; 44%). 35 interviews were conducted (31/41 (76%) accepted and 4/16 (25%) declined LORIS). At interview acceptors commented that the PIS was very useful and clear (84%; 26/31 & 90%; 28/31, respectively). 74% (23/31) of women who joined LORIS watched the DVD and the majority (19/23; 83%) found it “very useful” and 22 (22/23; 96%) “very easy to understand”. A third of women (10/31) said the PIS and the DVD helped them decide to participate in LORIS. Women who declined the trial had clear treatment preferences; 2/4 did not watch the DVD. Three quarters of women interviewed (19/25) watched the DVD with family members/friends and found it reassuring. One commented it was “Put in words you can understand and not be baffled by”. The most popular aspect was the Q&A session (13/25; 52%). Conclusions:The LORIS DVD was a useful, easy to understand recruitment tool, complementing the PIS. Many women felt reassured that the content was consistent with, and added to that provided by healthcare professionals. Opinions of family and friends, worries about randomisation and personal preferences exert an influence of those declining these types of trial. Fallowfield LJ, Jenkins V, et al. (1998) Attitudes of patients to randomised clinical trials of cancer therapy. Eur J Cancer 34(10):1554–1559. Citation Format: Fallowfield LJ, Matthews L, Jenkins VA, May SF, Francis A, Rae D, Wallis M. Interview data from women contemplating LORIS trial entry during the feasibility study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT3-08-01.