Proof of concept of a fully unsupervised anomaly detection framework in CBCT-guided radiotherapy.

Background: Anomalies in cone beam computed tomography (CBCT) radiotherapy image guidance, such as setup misalignments and soft-tissue variations, can be indicative of treatment deviations potentially impacting quality and safety. Repetitive review of routine alignment images by human observers is inefficient, prone to cognitive biases, and poorly suited for the detection of rare events.

Purpose: We propose an unsupervised image-guidance anomaly recognition and detection (iGuARD) framework, based on a CBCT inpainting technique using a variational autoencoder (VAE), which would highlight anomalies for human review.

Impact of Precision-Guided Dosing on Clinical Decision-Making and Health Care Utilization in Inflammatory Bowel Disease: A Retrospective Pretest/Posttest Real-World Study.

Background: Precision-guided dosing (PGD) is a personalized tool that optimizes clinical decision-making in the treatment of inflammatory bowel disease (IBD) with infliximab (IFX) and its biosimilars. PGD employs nonlinear mixed-effect models using patient-specific pharmacokinetic parameters to predict infliximab trough concentrations without the need to wait until the actual trough measurement. This approach calculates patient-specific clearance (CL) and provides tailored IFX dosing and administration intervals aimed at achieving target trough levels.

Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study.

Background & Aims: Subcutaneous (SC) induction and maintenance with guselkumab was evaluated in adult participants with moderately to severely active Crohn's disease.

Methods: The Phase 3 double-blind, placebo-controlled, treat-through GRAVITI study randomized 347 participants 1:1:1 to guselkumab 400 mg SC every 4 weeks→100 mg SC every 8 weeks (n = 115), guselkumab 400 mg SC every 4 weeks→200 mg SC every 4 weeks (n = 115), or placebo (n = 117). Placebo participants meeting rescue criteria received guselkumab from week 16 onward.

Mediators of Filgotinib Treatment Effects in Ulcerative Colitis: Exploring Circulating Biomarkers in the Phase 2b/3 SELECTION Study.

Background: We utilized patient samples from the large, phase 2b/3 SELECTION trial to identify circulating biomarkers of ulcerative colitis (UC) and potential early mediators of filgotinib treatment effects.

Methods: Samples were collected at baseline and during the induction phase of the SELECTION trial. Evaluated biomarkers comprised serum and stool proteins (measured by enzyme-linked immunosorbent assay), whole-blood cell counts, and whole-blood RNA-seq-derived gene-expression factors identified via exploratory factor analysis.

Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial.

Background: There is a need for efficacious therapies for patients with Crohn's disease that are better tolerated and more durable than available treatments. We aimed to evaluate the efficacy and safety of filgotinib, an oral Janus kinase 1 preferential inhibitor, for treating Crohn's disease.

Methods: This phase 3, double-blind, randomised, placebo-controlled trial was conducted in 371 centres in 39 countries.

Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis.

Background: Tulisokibart is a tumor necrosis factor-like cytokine 1A (TL1A) monoclonal antibody in development for the treatment of moderately to severely active ulcerative colitis. A genetic-based diagnostic test was designed to identify patients with an increased likelihood of response.

Methods: We randomly assigned patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo.

Centralized Quality Assurance of Stereotactic Body Radiation Therapy for the Veterans Affairs Cooperative Studies Program Study Number 2005: A Phase 3 Randomized Trial of Lung Cancer Surgery or Stereotactic Radiotherapy for Operable Early-Stage Non-Small Cell Lung Cancer (VALOR).

Purpose: The phase 3 Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy study implemented centralized quality assurance (QA) to mitigate risks of protocol deviations. This report summarizes the quality and compliance of the first 100 participants treated with stereotactic body radiation therapy (SBRT) in this study.

Methods And Materials: A centralized QA program was developed to credential and monitor study sites to ensure standard-of-care lung SBRT treatments are delivered to participants.

Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience.

The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study.

Real-World Patterns and Economic Burden Associated With Treatment Failure With Advanced Therapies in Patients With Moderate-to-Severe Ulcerative Colitis.

Background: Some patients lose response during treatment for moderate-to-severe ulcerative colitis (UC). We aimed to characterize real-world treatment failure patterns and associated economic burdens during use of first-line advanced therapies for UC.

Methods: IBM MarketScan Commercial and Medicare Supplemental Databases were used to identify adults initiating ≥ 1 advanced therapy for UC (January 1, 2010-September 30, 2019).

Clinical physicists' perceptions of weekly chart checks and the potential role for automated image review assessed by structured interviews.

Background: This study utilizes interviews of clinical medical physicists to investigate self-reported shortcomings of the current weekly chart check workflow and opportunities for improvement.

Methods: Nineteen medical physicists were recruited for a 30-minute semi-structured interview, with a particular focus placed on image review and the use of automated tools for image review in weekly checks. Survey-type questions were used to gather quantitative information about chart check practices and importance placed on reducing chart check workloads versus increasing chart check effectiveness.

Results of an Artificial Intelligence-Based Image Review System to Detect Patient Misalignment Errors in a Multi-institutional Database of Cone Beam Computed Tomography-Guided Radiation Therapy.

Purpose: Present knowledge of patient setup and alignment errors in image guided radiation therapy (IGRT) relies on voluntary reporting, which is thought to underestimate error frequencies. A manual retrospective patient-setup misalignment error search is infeasible owing to the bulk of cases to be reviewed. We applied a deep learning-based misalignment error detection algorithm (EDA) to perform a fully automated retrospective error search of clinical IGRT databases and determine an absolute gross patient misalignment error rate.

Clinical Long-Term Outcomes of Patient-Reported Outcomes in the Prospective Real-World Tofacitinib Response in Ulcerative Colitis Registry.

Introduction: We previously reported the results of tofacitinib induction therapy in the prospective multisite US real-world Tofacitinib Response in Ulcerative Colitis registry. We now assessed patient-reported outcomes (PROs) and predictors of success during tofacitinib maintenance therapy.

Methods: Tofacitinib Response in Ulcerative Colitis included 103 patients with refractory ulcerative colitis (UC); 67% had failed ≥ 2 biologics.

Proof-of-concept study of artificial intelligence-assisted review of CBCT image guidance.

Purpose: Automation and computer assistance can support quality assurance tasks in radiotherapy. Retrospective image review requires significant human resources, and automation of image review remains a noteworthy missing element in previous work. Here, we present initial findings from a proof-of-concept clinical implementation of an AI-assisted review of CBCT registrations used for patient setup.

Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies.

Objectives: The phase 2 MANTA and MANTA-RAy studies aimed to determine if the oral Janus kinase 1 preferential inhibitor filgotinib affects semen parameters and sex hormones in men with inflammatory diseases.

Methods: MANTA (NCT03201445) and MANTA-RAy (NCT03926195) included men (21-65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), respectively. Eligible participants had semen parameters in the normal range per the WHO definition.

Multimetallic glycerolate as a precursor template of spherical porous high-entropy oxide microparticles.

High-entropy materials have received notable attention concern on account of their unique structure, tunable properties, and unprecedented potential applications in many fields. In this work, for the first time a NiCoMnZnMg-containing high-entropy glycerolate (HE-Gly) particles has been synthesized using a scalable solvothermal method. The HE-Gly particles were used as a precursor in design of porous high-entropy oxide (HEO) microparticles.

Rapid and Sustained Symptom Relief in Patients With Ulcerative Colitis Treated With Filgotinib: Data From the Phase 2b/3 SELECTION Trial.

Introduction: Patients with ulcerative colitis (UC) regard rapid onset of action among the most important aspects of their treatment. We used the partial Mayo Clinic Score (pMCS) and component patient-reported subscores to assess the rapidity and sustainability of response to filgotinib, a once-daily, oral Janus kinase 1 preferential inhibitor, in adults with moderately to severely active UC in the phase 2b/3 SELECTION trial. The association between early symptomatic improvements and health-related quality of life (HRQoL) outcomes was also assessed.

Development and interinstitutional validation of an automatic vertebral-body misalignment error detector for cone-beam CT-guided radiotherapy.

Background: In cone-beam computed tomography (CBCT)-guided radiotherapy, off-by-one vertebral-body misalignments are rare but serious errors that lead to wrong-site treatments.

Purpose: An automatic error detection algorithm was developed that uses a three-branch convolutional neural network error detection model (EDM) to detect off-by-one vertebral-body misalignments using planning computed tomography (CT) images and setup CBCT images.

Methods: Algorithm training and test data consisted of planning CTs and CBCTs from 480 patients undergoing radiotherapy treatment in the thoracic and abdominal regions at two radiotherapy clinics.

AAPM MEDICAL PHYSICS PRACTICE GUIDELINE 5.b: Commissioning and QA of treatment planning dose calculations-Megavoltage photon and electron beams.

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education, and professional practice of medical physics. The AAPM has more than 8000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States.

Appropriate cleaning reduces potential risk of spore transmission from patients with Clostridioides difficile infection treated in outpatient infusion centers.

Objectives: Patients with Clostridioides difficile infection (CDI) who receive treatment at outpatient infusion centers (OICs) pose a risk for spore transmission. We investigated C. difficile contamination in the environment of CDI and non-CDI patients and evaluated the effectiveness of standard cleaning.

Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting.

Background: Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study.

Methods: Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56.