Sherbrooke

Preterm birth before 37 weeks' gestation is common and linked to many health challenges, especially when it occurs before 29 weeks. At this early stage, infants often face breathing difficulties due to immature lungs, sometimes requiring resuscitation. This study aims to compare two oxygen concentrations, 30% and 60%, used during resuscitation of very preterm infants to determine which leads to better survival and neurodevelopmental outcomes by about two years of age. The study uses a cluster randomized crossover design, where hospitals alternate between using 30% and 60% oxygen to resuscitate infants born between 23 and 28 weeks gestation. Infants receive the assigned oxygen concentration for the first 5 minutes after birth, with adjustments made based on oxygen saturation levels to maintain safe ranges. The intervention lasts 10 minutes, including initial resuscitation and oxygen titration to stabilize the infant. Participants will be closely monitored during their hospital stay and followed up at 24 months corrected age to assess survival and major neurodevelopmental outcomes. Data collected will include oxygen saturation, heart rate during resuscitation, and longer-term health measures. The study's results aim to guide safer oxygen use in resuscitating extremely preterm infants worldwide.

Researchers are evaluating the safety of the PET radiotracer 68Ga-DOTA-TATE in patients with neuroendocrine tumors (NETs). This pragmatic, prospective, and open-label clinical trial aims to establish 68Ga-DOTA-TATE PET/CT imaging as a standard diagnostic tool for NETs across Canada. Previous studies have already shown that this imaging method is superior to the former standard, Octreoscan, and this study seeks to gather additional data to support its routine use in clinical care. Participants receive an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE followed by a saline flush. After 45 to 90 minutes, a PET/CT scan is performed to capture detailed images. This single-center study has no control group and focuses on monitoring the safety profile of the radiotracer over a five-year period. During the study, participants will undergo PET/CT imaging after the injection and be monitored for any safety concerns related to the radiotracer. The primary outcome measured is the safety profile of 68Ga-DOTA-TATE over five years. The study involves informed consent and includes patients with suspected or confirmed tumors expressing somatostatin receptors. Researchers will also collect clinical data to help support implementation of this imaging technique as a new standard of care for neuroendocrine tumors.

Neuroblastoma is the most common extracranial tumor in children, occurring in about 10.2 per million children yearly. This phase II pilot study aims to evaluate the feasibility and safety of using 68Ga-DOTATATE PET/CT imaging for detecting neuroblastoma and to compare its imaging results directly with those from 123I-MIBG scintigraphy in the same patients. The study includes both children and adults with confirmed or suspected neuroblastoma, addressing the challenges caused by differences in imaging methods that can lead to varied treatment plans. Participants will receive an injection of the radiopharmaceutical 68Ga-DOTATATE followed by a PET/CT scan lasting about 2 hours, performed a few days after their 123I-MIBG scan. This study uses advanced PET imaging technology that may offer clearer tumor visualization compared to traditional methods. The research is designed as a single-arm, non-randomized trial conducted over a 2-year follow-up period. During the study, clinical data including demographics, treatments, medications, pathology, and lab results will be collected from medical records. Researchers will monitor the rate of participant enrollment throughout the 6-year study duration and track any adverse events occurring within 24 hours after the 68Ga-DOTATATE injection. The study emphasizes safety and effectiveness of the radiopharmaceutical imaging and includes long-term follow-up to assess outcomes.

Upper gastrointestinal (GI) cancers, including adenocarcinomas of the esophagus, stomach, bile ducts, and pancreas, are a significant health concern with limited treatment options at the metastatic stage. This research evaluates the potential use of endoradiotherapy (ERT) with 177Lu-PSMA, a targeted radiation therapy, for these cancers. The study aims to confirm if patients with upper metastatic gastric cancers are eligible for 177Lu-PSMA treatment by using 68Ga-PSMA PET/CT imaging to assess tumor uptake, following criteria from the European Association of Nuclear Medicine (EANM).

Researchers are evaluating the safety and use of cyclotron-produced 68Ga-PSMA-617 PET imaging in patients with solid cancers that express PSMA. While this imaging method is commonly used in prostate cancer, recent findings show that many solid tumors also have high PSMA expression in their new blood vessels. This study aims to introduce 68Ga-PSMA-617 PET as a routine tool for detecting and monitoring these cancers and to assess how it impacts patient care compared to current standard methods. The study involves giving participants an intravenous injection of the radiopharmaceutical 68Ga-PSMA-617 followed by a saline flush. After 60 to 90 minutes, participants undergo PET/CT imaging to visualize tumors that express PSMA. This is a single-site, open-label, non-randomized study without a control group, focusing on the diagnostic use of this imaging agent in various solid cancers. The imaging is expected to help with disease staging, follow-up, and therapy monitoring. Participants will be monitored for treatment-related adverse events over a five-year period to evaluate safety and tolerability. The study collects clinical data including PET/CT scan results and examines how this imaging method influences clinical management decisions. The total duration of participation depends on follow-up and standard care procedures. This study includes only patients who have a clinical order for the scan and provide informed consent.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. This Phase 3 study aims to evaluate the safety and effectiveness of combining sacituzumab tirumotecan (sac-TMT), an antibody drug that targets cancer cells, with pembrolizumab and bevacizumab. The study seeks to find out if this combination can help people live longer or keep their cancer from worsening compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT together with pembrolizumab and bevacizumab to assess safety. In Part 2, after standard initial treatment, those whose cancer does not progress will be randomly assigned to maintenance treatment with either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may be added during maintenance treatment based on the doctor's decision. All treatments are given through intravenous infusions, and participants may receive rescue medications to manage side effects before sac-TMT infusion. Participants will be monitored for adverse events and treatment tolerability over several months. The study measures include progression-free survival and overall survival, assessed by independent review. Safety and treatment continuation rates are tracked during Part 1 for up to approximately 66-69 months, while Part 2 outcome measures extend up to 48-60 months. Various assessments, including laboratory tests and evaluations of cancer status, will be performed throughout the study to understand treatment effects and participant well-being.