Edmonton

Researchers are investigating CGT9486, also known as bezuclastinib, in an open-label Phase 2 study for patients with Advanced Systemic Mastocytosis AdvSM. This includes those diagnosed with Aggressive Systemic Mastocytosis ASM, Systemic Mastocytosis with an Associated Hematologic Neoplasm SM-AHN, and Mast Cell Leukemia MCL. The study aims to evaluate the safety, effectiveness, pharmacokinetics, and pharmacodynamics of bezuclastinib in this patient population. Participants will receive bezuclastinib tablets orally, taken continuously in 28-day cycles. The study is divided into two parts Part I focuses on identifying effective and tolerable dosing exposures over 18 months, while Part II evaluates the drugs efficacy by measuring objective response rates and confirming the exposure-response relationship, also over 18 months. Additional assessments include effects on mutation allele burden, serum tryptase levels, histopathologic changes, spleen and liver volume, and safety monitoring. During the study, participants will undergo various clinical evaluations, including laboratory tests, imaging to monitor organ size changes, and assessments of disease response and progression. Researchers will track adverse events and pharmacokinetic profiles throughout the 18 months. The study involves continuous monitoring of participants to understand the treatments impact on survival and disease progression over this period.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating the optimization of 18F-DOPA PETCT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinsons disease or Lewy body dementia. The study aims to improve image quality using a new digital PETCT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PETCT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

Researchers are evaluating the use of 18F-PSMA-1007 PETCT imaging in adult men with prostate cancer, particularly those with a history of radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy, or who have high-risk features for metastatic disease. This phase III study aims to assess the safety of the 18F-PSMA-1007 tracer and to analyze non-specific bone lesions detected during imaging. Participants include men aged 18 and older with specific PSA levels or clinical features related to prostate cancer. Participants will receive a single intravenous injection of 18F-PSMA-1007 at a dose of 4 MBqkg up to a maximum of 400 MBq. The study involves imaging with PETCT following tracer injection to observe the distribution and activity of the tracer. The safety of the tracer will be monitored immediately after injection, after the scan approximately 2.5 hours later, and for delayed adverse events up to 7 days post-injection. Researchers will also follow non-specific bone lesions identified during the scan for at least one year to determine their nature. During the study, participants will be screened for adverse effects at multiple time points, including immediately post-injection and post-scan. They will receive information to self-report any delayed side effects occurring within one week after injection. The study will record and evaluate up to five non-specific bone lesions per participant, tracking their size and location. Safety assessments continue for up to a year after the scan to better understand the clinical relevance of these lesions. Participation duration varies depending on follow-up assessments.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low 30% or high 60% oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infants oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

The trial investigates the use of 3D transesophageal echocardiography TEE to analyze the right ventricles function in patients undergoing left ventricular assist device LVAD implantation. LVADs help support the left ventricle in patients with severe heart failure. Because right ventricular failure after LVAD implantation is common and linked to complications, this study aims to better predict which patients are at higher risk by using advanced 3D imaging methods. Participants receive one of several types of left-sided LVADs, including HeartMate III, HeartWare HVAD, or Levitronix CentriMag devices. During the LVAD implantation procedure, 3D TEE images of the right ventricle are taken and analyzed. The study focuses on gathering detailed heart function data and does not involve additional treatments or interventions beyond standard device implantation. During the study, researchers collect various heart function measurements within 24 hours after implantation, such as ventricular strain, volumes, ejection fractions, and tricuspid annular plane systolic excursion. Secondary outcomes include monitoring clinical data and lab tests over 14 days post-implantation. Participants are observed for right ventricular function and related support needs. The study started in March 2022 and will continue through January 2027, involving no experimental treatments beyond imaging and data collection.

Researchers are evaluating the safety and diagnostic accuracy of 68Ga-HA-DOTATATE PETCT imaging for patients with known or suspected somatostatin receptor positive tumors, such as gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others. This phase II, single-center, non-randomized study aims to assess this new tracer produced at the Edmonton Radiopharmaceutical Centre, comparing it to standard CT or MRI imaging over a one-year follow-up period. Participants will receive a single intravenous dose of 68Ga-HA-DOTATATE at 2.64 MBqkg, with a minimum of 37 MBq and maximum of 250 MBq, followed by PETCT scanning. Up to 600 scans will be performed over six years, including both adult and pediatric patients. Some patients may undergo multiple scans during the study. Safety will be monitored immediately after injection, post-scan, and at 10 days, while efficacy will be evaluated by comparing imaging results to clinical follow-up. During the study, participants will undergo PETCT scans and standard clinical CT or MRI within six months before enrollment. Adverse events will be tracked closely in the Nuclear Medicine department, and diagnostic accuracy will be assessed through sensitivity and specificity measures at one year post-scan. The study duration allows for comprehensive safety and efficacy evaluations, helping to inform clinical care for patients with these tumors.

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.