Standard Clinical Use Research Articles

Management of complications of chimeric antigen receptor T-cell therapy: a report by the European Society of Blood and Marrow Transplantation.

CAR-T cells are in standard clinical use to treat relapsed or refractory hematologic malignancies, such as non-Hodgkin's lymphoma, multiple myeloma and acute lymphoblastic leukemia. Owing to the rapidly progressing field of CAR-T cell therapy and the lack of generally accepted treatment guidelines, we hypothesized significant differences between European centers in prevention, diagnosis and management of short- and long-term complications. To capture the current CAR-T cell management among EBMT centers and to determine the medical need and specific areas for future clinical research the EBMT Transplant Complications Working Party performed a survey among 227 EBMT CAR-T cell centers. We received complete servey answers from 106 centers (47%) addressing questions in the areas of product selection, CAR-T cell logistics, management of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome as well as management in later phases including prolonged cytopenias. We identified common patterns in complication management, but also significant variety in clinical management of the centers in important aspects. Our results demonstrate a high medical need for treatment harmonization and future clinical research in the following areas: treatment of steroid-refractory and very severe CRS/neurotoxicity, treatment of cytopenia, early discharge and outpatient management, as well as immunoglobulin substitution.

Lessons from the pandemic and the value of a structured system of ultrasonographic findings in the diagnosis of COVID-19 pulmonary manifestations.

We aimed to share our experience in implementing a structured system for COVID-19 lung findings, elucidating key aspects of the lung ultrasound score to facilitate its standardized clinical use beyond the pandemic scenario. Using a scoring system to classify the extent of lung involvement, we retrospectively analyzed the ultrasound reports performed in our institution according to COVID-RADS standardization. The study included 69 thoracic ultrasound exams, with 27 following the protocol. The majority of patients were female (52%), with ages ranging from 1 to 96 years and an average of 56 years. Classification according to COVID-RADS was as follows: 11.1% in category 0, 37% in category 1, 44.4% in category 2, and 7.4% in category 3. Ground-glass opacities on tomography correlated with higher COVID-RADS scores (categories 2 and 3) in 82% of cases. Ventilatory assessment revealed that 50% of cases in higher COVID-RADS categories (2 and 3) required second-line oxygen supplementation, while none of the cases in lower categories (0 and 1) utilized this support. Lung ultrasound has been widely utilized as a diagnostic tool owing to its availability and simplicity of application. In the context of the pandemic emergency, a pressing need for a focused and easily applicable assessment arose. The structured reporting system, incorporating ultrasound findings for stratification, demonstrated ease of replicability. This system stands as a crucial tool for screening, predicting severity, and aiding in medical decisions, even in a non-pandemic context. Lung ultrasound enables precise diagnosis and ongoing monitoring of the disease. Ultrasound is an effective tool for assessing pulmonary findings in COVID-19. Structured reports enhance communication and are easily reproducible.

ATG or Post-Transplant Cyclophosphamide to Prevent Gvhd in Matched Unrelated Stem Cell Transplantation? - a Registry Analysis By the EBMT Transplant Complications Working Party

T There is a considerable risk of GVHD and non-relapse mortality (NRM) after allogeneic stem cell transplantations (alloSCT) when matched unrelated donors (MUD) are used. Prophylaxis with either rabbit anti-thymocyte globulin (rATG, also termed anti-T-lymphocyte globulin) or post-transplantation Cyclophosphamide (PTCy) is in standard clinical use. The unresolved question is whether to prefer PTCy or rATG in this setting. So far, two randomized trials, several retrospective studies and a meta-analysis comparing PTCy to rATG in MUD alloSCT gave contradictory results. Current data from large registry cohorts has not been published. To improve the evidence base, we analyzed outcomes of rATG vs. PTCy prophylaxis in adult patients with hematologic malignancies undergoing peripheral blood alloSCT from 10/10 antigen MUD between Jan 2018 and June 2021 in the EBMT database. We performed multivariate analyses using Cox cause-specific hazard models, adjusting for known risk factors, and variables that showed significant difference between the two comparison groups. Overall 8764 patients were included, treatment- and patient characteristics are shown in Table 1. Patients receiving PTCy (n=1039) were younger, had undergone alloSCT more recently, and had a lower disease risk compared to patients receiving rATG (n=7725). Median follow up was 2.1 years in both groups. Outcomes graphs are shown in figure 1. All outcomes are given starting from alloSCT (with 95% CI): NRM (fig 1A) was higher in the rATG arm (2-years NRM: PTCy 12.4% [10.2 - 14.7] vs. rATG 16.1% [15.3 - 17]; HR 0.72, p=0.016), same for Relapse incidence, (2-years RI: PTCy 22.8% [19.9 - 25.8] vs. rATG 26.6% [25.5 - 27.7]; HR 0.87, p=0.046), Overall survival (fig 1B) was better in the PTCy arm (2-years OS: PTCy 73.1% [70 - 76] vs. rATG 65.9% [64.7 - 67.1]; HR 0.82, p=0.001), same for Progression free survival (fig 1C) (2-years PFS: PTCy 64.9% [61.4 - 68.1] vs. rATG 57.2% [56 - 58.5]; HR 0.83, p<0.001), Chronic GVHD was lower in the PTCy arm (2-years cGVHD: PTCy 28.4% [25.2 - 31.7] vs. rATG 31.4% [30.3 - 32.6]; HR 0.77, p=0.012), whereas acute GVHD grades II-IV was not significantly different between the two arms (100-day aGVHD: PTCy 24.1% [21.3 - 27] vs. rATG 26.5% [25.5 - 27.6]; HR 0.85, p=0.11) In conclusion, we found a lower NRM, lower incidence of chronic GVHD as well as higher survival outcomes in adult recipients of peripheral blood alloSCTs from MUD receiving PTCy compared to rATG. The current analysis improves the evidence basis for decision making on GVHD prophylaxis in MUD alloSCT.

Noradrenaline tracks emotional modulation of attention in human amygdala

The noradrenaline (NA) system is one of the brain's major neuromodulatory systems; it originates in a small midbrain nucleus, the locus coeruleus (LC), and projects widely throughout the brain.1,2 The LC-NA system is believed to regulate arousal and attention3,4 and is a pharmacological target in multiple clinical conditions.5,6,7 Yet our understanding of its role in health and disease has been impeded by a lack of direct recordings in humans. Here, we address this problem by showing that electrochemical estimates of sub-second NA dynamics can be obtained using clinical depth electrodes implanted for epilepsy monitoring. We made these recordings in the amygdala, an evolutionarily ancient structure that supports emotional processing8,9 and receives dense LC-NA projections,10 while patients (n= 3) performed a visual affective oddball task. The task was designed to induce different cognitive states, with the oddball stimuli involving emotionally evocative images,11 which varied in terms of arousal (low versus high) and valence (negative versus positive). Consistent with theory, the NA estimates tracked the emotional modulation of attention, with a stronger oddball response in a high-arousal state. Parallel estimates of pupil dilation, a common behavioral proxy for LC-NA activity,12 supported a hypothesis that pupil-NA coupling changes with cognitive state,13,14 with the pupil and NA estimates being positively correlated for oddball stimuli in a high-arousal but not a low-arousal state. Our study provides proof of concept that neuromodulator monitoring is now possible using depth electrodes in standard clinical use.

Operational Ontology for Radiation Oncology (OORO): A Professional Society-Based, Multi-Stakeholder Consensus Driven Informatics Standard Supporting Clinical and Research Use of Real-World Data

There is a critical need for large-scale, multi-institutional "real-world" data to evaluate patient, diagnosis and treatment factors affecting oncology patient outcomes. However, lack of data standardization undermines the potential for automated learning from the vast amount of information routinely archived in electronic health records (EHRs), Radiation Oncology Information Systems and other cancer care databases. As next step to promote data standardization beyond the American Association of Physicists in Medicine (AAPM)'s TG-263 guidance for radiotherapy (RT) nomenclature, the AAPM's Big Data Subcommittee (BDSC) has led an international RT professional society collaboration to develop the Operational Ontology for Radiation Oncology (OORO). Initiated July 2019 to explore issues that typically compromise formation of large inter- and intra- institutional databases from EHRs, the AAPM's BDSC membership includes representatives from the AAPM, American Society of Radiation Oncology (ASTRO), Canadian Organization of Medical Physicists (COMP), Canadian Association of Radiation Oncology (CARO), European Society of Therapeutic Radiation Oncology (ESTRO) and clinical trials experts from NRG Oncology. Multiple external stakeholders were engaged, including government agencies, vendors and RT community members through the iterative and consensus-driven approach to OORO development. The OORO includes 42 key elements, 359 attributes, 144 value sets, and 155 relationships, ranked for priority of implementation based on clinical significance, likelihood of availability in EHRs, or ability to modify routine clinical processes to permit aggregation. The initial version of OORO includes many disease-site independent concepts common for all cancer patients and a smaller set specific for prostate cancer. The OORO development methodology is currently being applied/adapted to include additional disease site-specific concepts beginning with head and neck cancers. The first of its kind in radiation oncology, the OORO is a professional society-based, multi-stakeholder, consensus driven informatics standard. The iterative and collaborative approach to ontology development and refinement aims to ensure that OORO serves as a « living » guidance document, facilitating incremental expansion of data elements over time, as disease site-specific standards are set and RT concepts evolve. Supporting construction of comprehensive "real-world" datasets and application of advanced analytic techniques, including artificial intelligence (AI), OORO holds the potential to revolutionize patient management and improve outcomes.

62 Operational Ontology for Radiation Oncology (OORO) - a Professional Society-Based, Multi-Stakeholder Consensus Driven Informatics Standard Supporting Clinical and Research Use of Real-World Data

62 Operational Ontology for Radiation Oncology (OORO) - a Professional Society-Based, Multi-Stakeholder Consensus Driven Informatics Standard Supporting Clinical and Research Use of Real-World Data

Operational Ontology for Oncology (O3): A Professional Society-Based, Multistakeholder, Consensus-Driven Informatics Standard Supporting Clinical and Research Use of Real-World Data From Patients Treated for Cancer

The ongoing lack of data standardization severely undermines the potential for automated learning from the vast amount of information routinely archived in electronic health records (EHRs), radiation oncology information systems, treatment planning systems, and other cancer care and outcomes databases. We sought to create a standardized ontology for clinical data, social determinants of health, and other radiation oncology concepts and interrelationships. The American Association of Physicists in Medicine's Big Data Science Committee was initiated in July 2019 to explore common ground from the stakeholders' collective experience of issues that typically compromise the formation of large inter- and intra-institutional databases from EHRs. The Big Data Science Committee adopted an iterative, cyclical approach to engaging stakeholders beyond its membership to optimize the integration of diverse perspectives from the community. We developed the Operational Ontology for Oncology (O3), which identified 42 key elements, 359 attributes, 144 value sets, and 155 relationships ranked in relative importance of clinical significance, likelihood of availability in EHRs, and the ability to modify routine clinical processes to permit aggregation. Recommendations are provided for best use and development of the O3 to 4 constituencies: device manufacturers, centers of clinical care, researchers, and professional societies. O3 is designed to extend and interoperate with existing global infrastructure and data science standards. The implementation of these recommendations will lower the barriers for aggregation of information that could be used to create large, representative, findable, accessible, interoperable, and reusable data sets to support the scientific objectives of grant programs. The construction of comprehensive "real-world" data sets and application of advanced analytical techniques, including artificial intelligence, holds the potential to revolutionize patient management and improve outcomes by leveraging increased access to information derived from larger, more representative data sets.

Clinical Linear Accelerator-Based Electron FLASH: Pathway for Practical Translation to FLASH Clinical Trials

Ultrahigh-dose-rate (UHDR) radiation therapy (RT) has produced the FLASH effect in preclinical models: reduced toxicity with comparable tumor control compared with conventional-dose-rate RT. Early clinical trials focused on UHDR RT feasibility using specialized devices. We explore the technical feasibility of practical electron UHDR RT on a standard clinical linear accelerator (LINAC). We tuned the program board of a decommissioned electron energy for UHDR electron delivery on a clinical LINAC without hardware modification. Pulse delivery was controlled using the respiratory gating interface. A short source-to-surface distance (SSD) electron setup with a standard scattering foil was configured and tested on an anthropomorphic phantom using circular blocks with 3- to 20-cm field sizes. Dosimetry was evaluated using radiochromic film and an ion chamber profiler. UHDR open-field mean dose rates at 100, 80, 70, and 59 cm SSD were 36.82, 59.52, 82.01, and 112.83 Gy/s, respectively. At 80 cm SSD, mean dose rate was ∼60 Gy/s for all collimated field sizes, with an R80 depth of 6.1 cm corresponding to an energy of 17.5 MeV. Heterogeneity was <5.0% with asymmetry of 2.2% to 6.2%. The short SSD setup was feasible under realistic treatment conditions simulating broad clinical indications on an anthropomorphic phantom. Short SSD and tuning for high electron beam current on a standard clinical LINAC can deliver flat, homogenous UHDR electrons over a broad, clinically relevant range of field sizes and depths with practical working distances in a configuration easily reversible to standard clinical use.

Appropriate Use and Abuse of Sedative-Hypnotic Drugs

The incidence of insomnia has been increasing in recent years. In addition, due to the impact of the COVID-19 pandemic, more and more people are experiencing a variety of insomniac problems, including having difficulty in sleep initation, waking up too early, and short sleep duration. Chronic insomnia may seriously affect patients' life and work, increase their risks of developing physical and mental illnesses, and cause crushing social and economic burdens. Sedative-hypnotics, including benzodiazepine agonists, melatonin receptor agonists, orexin receptor antagonists, and antidepressants with hypnotic effects, are widely used to treat most patients suffering from insomnia. However, there is the phenomenon of the non-medical use and abuse of sedative-hypnotic drugs, especially benzodiazepine receptor agonists. The abuse of sedative-hypnotic drugs may lead to mental and physical dependence, cognitive impairment, depression and anxiety, as well as an increased risks of falls and death. Therefore, drug regulatory authorities in China and other countries have issued relevant policies to reinforce regulation. Herein, we reviewed the prevalent use and safety of sedative-hypnotic drugs and proposed suggestions concerning their appropriate use. Both the efficacy and safety of sedative-hypnotic drugs should be carefully considered so that patients suffering from insomnia receive thorough and prompt treatment and the problem of potential abuse of sedative-hypnotic drugs is assessed in an objective and scientific manner. We also hope to provide references for the standardized clinical use of insomnia drugs.

Photon-Counting Computed Tomography (PCCT): Technical Background and Cardio-Vascular Applications

Photon-counting computed tomography (PCCT) is a new advanced imaging technique that is going to transform the standard clinical use of computed tomography (CT) imaging. Photon-counting detectors resolve the number of photons and the incident X-ray energy spectrum into multiple energy bins. Compared with conventional CT technology, PCCT offers the advantages of improved spatial and contrast resolution, reduction of image noise and artifacts, reduced radiation exposure, and multi-energy/multi-parametric imaging based on the atomic properties of tissues, with the consequent possibility to use different contrast agents and improve quantitative imaging. This narrative review first briefly describes the technical principles and the benefits of photon-counting CT and then provides a synthetic outline of the current literature on its use for vascular imaging.

Transcranial Alternating Current Stimulation (tACS) for Major Depressive Disorder

The 21st century has brought forth major advancements in device-based treatments for psychiatric disorders such as major depressive disorder (MDD). One of the most exciting technologies on the rise in this field is transcranial alternating current stimulation (tACS). The small but rapidly growing body of knowledge on tACS suggests that this wearable, low-cost, noninvasive neuromodulation method could provide a safe and effective alternative, or augmentation, to pharmacological interventions for MDD. While device parameters for treatment of MDD need refinement before this method is ready for standardized clinical use, we expect that tACS will make a significant impact on psychiatric treatment in the coming years. [ Psychiatr Ann . 2022;52(11):456–460.]

Management guideline for the off-label use of medicine in China (2021)

ABSTRACT Background Off-label drug use embodies a thorough clinical diagnosis and evaluation of treatment needs and should not be confused with unreasonable drug use, but it also faces potential risks with drug safety and legal issues. Research design and methods We first established a guideline working group. Following the guideline development process recommended by the World Health Organization Handbook and the Chinese Medical Association, the key questions were determined through literature searches of PubMed, CNKI (Chinese National Knowledge Infrastructure) and other databases. Both the evidence and the clinicians’ diagnosis and treatment workload were considered to formulate the initial recommendations. Finally, two rounds of Delphi surveys and one expert seminar were organized to determine the final recommendations of this guideline. Meanwhile, we graded the recommendations based on the body of evidence. Results We determined nine questions and proposed a total of 23 recommendations regarding the definition of off-label use of drugs, applicable circumstances, classification of evidence, informed consent, legal basis, adverse drug reaction monitoring and evaluation, management procedure, responsibilities and obligations of different stakeholders, medical insurance reimbursement, and the national approval system. Conclusions This guideline standardized clinical off-label drug use and provided suggestions and references for the management of off-label drug use.

The therapeutic potential of psilocybin: a systematic review

ABSTRACT Introduction Psychedelic drugs were used quite extensively before their prohibition in 1968 which delayed research. However, since the 1990s, studies on the potential therapeutic benefits of psychedelics have rapidly increased. Areas covered This systematic review provides an overview of the clinical effects of psilocybin in the treatment of a variety of mental disorders. Only (randomized) clinical trials were selected. A total of 11 studies (15 publications) were selected, including seven randomized controlled trials (eight publications) and four single arm open-label studies (seven publications). In total, 488 patients were included in the selected studies: 333 patients treated with psilocybin and 155 patients treated with (active) placebo. In nine studies, psychotherapeutic support was provided as an integral part of the psilocybin treatment. The findings of these studies collectively show that psilocybin has a positive benefit–risk balance in the treatment of various mental disorders with an immediate and prolonged effect following 1–3 doses of psilocybin and a few (serious) adverse events. Expert opinion Psilocybin – mostly combined with psychotherapy or psychotherapeutic support – shows a promise as a treatment for various (treatment-resistant) mental disorders. Larger double-blind RCTs with objective (long-term) outcomes are needed to confirm these findings before standard clinical use of psilocybin can be considered.

How to Assess EVLP Lungs in Standard Clinical Use?

<h3>Purpose</h3> Ex-vivo lung perfusion (EVLP) is currently considered a valuable option to preserve, reassess or recondition pulmonary grafts prior to lung transplantation (LTx). Both standard and extended criteria donors lungs have been studied in clinical trials. Usually, a 20% deterioration of physiological parameters during EVLP is considered detrimental for the graft and a reason to decline it. In this study, we report the relation between EVLP parameters and primary graft dysfunction (PGD) in a clinical LTx program. <h3>Methods</h3> In our center the TransMedics OCS^TM Lung device is used. The indication for EVLP was combined organ transplantation, graft re-assessment or prolonged preservation based on an institutional algorithm and available resources. Standard clinical EVLP parameters (mean pulmonary artery pressure (PAP), vascular resistance (VR) and driving airway pressure(DAP)) were compared between the first and final assessment. The % difference (Δ) between these time points was calculated. Graft outcome was expressed as presence of any PGD grade 3 (PGD 3) within 72 hours. Statistical analysis was performed using student T-test comparing patients with PGD 3 vs. without. Combined organ (liver-LTx) and LTx cases were analyzed separately as well as together. <h3>Results</h3> Data are presented in figure 1. In total, 12 lungs were included. Overall, all grafts met acceptance criteria during EVLP and were transplanted. Despite this, 58% of the patients developed PGD 3. No statistically significant difference in EVLP parameters was observed between patients who developed and did not develop PGD 3. <h3>Conclusion</h3> Overall, the clinical EVLP parameters were within the limits of acceptance and even improved over time. Despite this, we observed a high incidence of PGD 3. At this moment it is not clear how to assess EVLP lungs in clinical use and predict the outcome after LTx. The role of EVLP in post-reperfusion injury requires further research.

Hydrodynamic Interaction Between Tear Film and Air Puff From Noncontact Tonometry.

PurposeThe purpose of this study was to investigate the mechanism of potential droplet formation in response to air puff deformation with two noncontact tonometers (NCTs).MethodsTwenty healthy volunteers were examined using two NCTs, Ocular Response Analyzer and Corvis ST, and two contact tonometers, iCare and Tono-Pen. High-speed videos of the tear film response were captured with at spatial resolution of 20 microns/pixel at 2400 fps. Droplet size, droplet velocity, distance between air puff impact location, and the tear meniscus-lid margin were characterized.ResultsOne subject was excluded due to technical issues. Droplets were detected only in tests with instilled eye drop. Videos showed the tear film rolls away from the apex while remaining adherent to the ocular surface due to the tendency of the fluid to remain attached to a solid surface explained by the Coanda effect. Twelve out of 38 videos with an eye drop administration showed droplet formation. Only one resulted in droplets with predominantly forward motion, which had the shortest distance between air puff impact location and lower meniscus. This distance on average was 5.9 ± 1.1 mm. The average droplet size was 500 ± 200 µm.ConclusionsResults indicate no droplet formation under typical clinical setting. Hence, standard clinical use of NCT tests is not expected to cause droplets. NCT testing with eye drop administration showed droplet formation at the inferior eyelid boundary, which acts as a barrier and interrupts tear flow.Translational RelevanceStudy of tear film interaction with NCT air puff shows that these tonometers are not expected to cause droplet formation in standard use and that if external drops are required, both eyelids should be held if patients need assistance to maintain open eyes to avoid droplets with predominantly forward motion.

Research advances in percutaneous cholecystostomy in treatment of acute cholecystitis

Acute cholecystitis is a common acute abdominal disease in hepatobiliary surgery, and laparoscopic cholecystectomy is the preferred treatment method for this disease. Percutaneous cholecystostomy for drainage plays a vital role in management of patients with cholecystitis who are unsuitable for surgery. This technique has good safety and can be used as a bridge to elective cholecystectomy or as a final treatment for some high-risk patients. However at present, the experience in the management of this technique varies across institutions. Therefore, this article reviews the research advances in percutaneous cholecystostomy in terms of indication, treatment timing, and management, so as to provide a basis for standard clinical use.

Spinal Fluid Myeloid Microvesicles Predict Disease Course in Multiple Sclerosis.

In vivo measures of myeloid activity are promising biomarkers in multiple sclerosis. We previously demonstrated that cerebrospinal fluid (CSF) myeloid microvesicles are markers of microglial/macrophage activity and neuroinflammation in multiple sclerosis. Here, we aimed at investigating the diagnostic and prognostic value of myeloid microvesicles in a clinical setting. Six hundred one patients discharged with a diagnosis of neuroinflammatory, neurodegenerative, or no neurological disease were enrolled. Myeloid microvesicles were measured with flow cytometry as isolectin B4-positive events in fresh CSF. Clinical, demographical, and magnetic resonance imaging (MRI) data were collected at diagnosis (all patients) and during follow-up (n=176). CSF myeloid microvesicles were elevated in neuroinflammatory patients compared to the neurodegenerative and control groups. In multiple sclerosis, microvesicles were higher in patients with MRI disease activity and their concentration increased along with the number of enhancing lesions (p < 0.0001, Jonckheere-Terpstra test). CSF myeloid microvesicles were also higher in patients with higher disease activity in the month and year preceding diagnosis. Microvesicles excellently discriminated between the relapsing-remitting and control groups (receiver operator characteristic curve, area under the curve=0.939, p < 0.0001) and between radiologically isolated syndrome and unspecific brain lesions (0.942, p < 0.0001). Furthermore, microvesicles were independent predictors of prognosis for both the relapsing-remitting and progressive groups. Microvesicles independently predicted future disease activity in relapsing-remitting patients (hazard ratio [HR]=1.967, 95% confidence interval [CI] = 1.147-3.372), correcting for prognostic factors of standard clinical use. In the progressive group, microvesicles were independent predictors of disability accrual (HR=10.767, 95% CI=1.335-86.812). Our results confirm that CSF myeloid microvesicles are a clinically meaningful biomarker of neuroinflammation and microglial/macrophage activity in vivo. These findings may support a possible use in clinical practice during diagnostic workup and prognostic assessment. ANN NEUROL 2021;90:253-265.

68Ga-DOTATATE PET/CT for Neuroblastoma Staging: Utility for Clinical Use

Metaiodobenzylguanidine (MIBG) imaging has been the standard for neuroblastoma staging for many decades. Novel agents such as 18F-DOPA and 68Ga-DOTATATE are being used nowadays in academic centers. During the coronavirus disease 2019 (COVID-19) pandemic, procurement of 123I-MIBG has proved particularly challenging, necessitating the use of 68Ga-DOTATATE PET. 68Ga-DOTATATE is Food and Drug Administration-approved for imaging of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Methods: 68Ga-DOTATATE PET/CT imaging was performed for staging of 3 pediatric patients with neuroblastoma at our institution. Areview of the literature was also completed. Results: 68Ga-DOTATATE PET/CT scans were successfully performed on all patients. All patients showed 68Ga-DOTATATE-avid disease. PET scans showed an excellent spatial resolution and demonstrated high accuracy in concordance with current European Association of Nuclear Medicine guidelines. Conclusion: We have presented 68Ga-DOTATATE PET/CT imaging for staging of neuroblastoma and believe it can reliably be used as an alternative to 123I-MIBG. It has technical, clinical, and practical advantages making it an attractive option. Further multicenter studies are required before it can be recommended for standard clinical use.

Clinical results of the BoneWelding\xaeFiji\xae anchor for the treatment of Stener lesions of the thumb

IntroductionA new technology (Sportwelding®) was recently presented, which uses ultrasonic energy to meld a resorbable suture anchor at the interface with the host bone. A standardized clinical use was not investigated yet. This study prospectively evaluated the surgical and clinical outcomes of the Fiji Anchor® (Sportwelding®, Schlieren, Switzerland) in the repair of an ulnar collateral ligament lesion of the metacarpophalangeal joint of the thumb.Material and methodsThe range of motion, grip and pinch strength, disability of arm, shoulder and the hand (DASH) and patient rated evaluation (PRWE) score, pain, satisfaction, complications and adverse events were assessed in 24 patients after surgical treatment for an acute displaced rupture or avulsion of the ulnar collateral metacarpophalangeal ligament of the thumb using the Fiji Anchor® after 6, 12 and 52 weeks.ResultsAt final follow up, the range of motion of the metacarpophalangeal joint reached almost the contralateral side (49.3° SD 11.7°). Thumb opposition showed a Kapandji score of 9.7 (SD 0.5; range 9–10). Grip strength, the lateral, tip and the three jaw pinch showed nearly similar values compared to the contralateral side (83–101%). Pain was low (0.2 SD 0.7 at rest and 0.6 SD 1.0 during load). The DASH score was 5.0 (SD 7.3) and the PRWE score was 4.1 (SD 9.0). 81% of patients were very satisfied at final follow-up. Two patients were rated unstable during the follow-up period due to a second traumatic event. Three cases experienced difficulties during anchor insertion, whereby incorrect anchor insertion resulted in damage to the suture material; however, this was resolved after additional training.ConclusionOne advantage of this anchor appears to be its stable fixation in cancellous bone. The surgical treatment of an ulnar collateral ligament lesion of the thumb using the Fiji Anchor® can lead to an excellent clinical outcome with a minor complication rate; however, long-term dangers and the cost effectiveness of the procedure are not known yet.

Lyophilized Autologous Serum Eyedrops: Experimental and Comparative Study

To analyze the biological stability of autologous serum eyedrops after lyophilization. Prospective, comparative experimental study. This was a comparative study with serum obtained from 12 healthy volunteers. The concentrations of different epitheliotropic factors (eg, transforming growth factor-β [TGF-β1], epidermal growth factor [EGF], platelet-derived growth factor AB [PDGF-AB], and albumin) were measured in fresh and lyophilized serum. The samples were studied after serum preparation (fresh serum) and immediately after saline solution reconstitution of lyophilized serum (0), 15, and 30days later. The biological effects of both serum samples were also compared on conjunctival and corneal cell cultures. The pH, osmolarity, and serum density were also determined. No significant differences were found in the concentration of growth factors between fresh serum and re-dissolved serum samples after lyophilization. The concentration of growth factors remained stable during 1month at 4°C in re-dissolved lyophilized form with saline solution. No differences were found related to osmolarity, pH, and density between fresh and lyophilized serum. In addition, no differences were found on the conjunctival and corneal cells proliferation and differentiation in cells cultures between either serum preparation. The properties of autologous serum remain after lyophilization. The lyophilized serum can be easily stored without temperature restrictions and easily reconstituted for preparation of eyedrops for standard clinical use.