Edmonton

Researchers are investigating the drug bezuclastinib in an open-label, two-part Phase 2 study for patients with Advanced Systemic Mastocytosis (AdvSM), including 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, and how the drug behaves in the body for these serious conditions. Bezuclastinib is given orally as tablets taken continuously in 28-day cycles. The study has two parts: Part I focuses on identifying safe and tolerable doses of bezuclastinib over 18 months, while Part II evaluates its effectiveness by measuring the objective response rate and confirming the relationship between drug exposure and response during another 18-month period. Participants will undergo assessments including clinical evaluations, laboratory tests, and monitoring of their disease status to determine treatment effects and safety. Researchers will track the drug's impact on the disease and patient health throughout the study, which involves continuous treatment and follow-up over the specified time frames.

Researchers are evaluating the use of 18F-DOPA PET/CT imaging to improve the detection and assessment of various conditions including congenital hyperinsulinism, neuroblastoma, neuroendocrine tumors, Parkinson's disease, Lewy body dementia, and brain tumors. This phase III prospective cohort study aims to optimize imaging by assessing new digital PET/CT technology and the effect of intravenous furosemide on image quality, particularly in the pelvis. Additionally, the study investigates gallbladder activity patterns and explores possible links between brain and gallbladder dopaminergic denervation. Participants will receive an intravenous injection of 18F-DOPA at a dose of 4MBq/kg (minimum 110 MBq, maximum 600 MBq). Some patients will also be given a single intravenous dose of 40mg furosemide before imaging to improve scan quality. Imaging will be performed using a new PET/CT scanner with digital detectors and advanced reconstruction algorithms. A subgroup will undergo dynamic abdominal scans to study gallbladder activity over time. The study plans to enroll 800 patients over about five years, with approximately 160 scans yearly. During the study, researchers will measure lesion size and activity, bladder activity and artifacts, and gallbladder uptake at multiple time points. Participants will complete questionnaires about gallbladder disease history. Imaging results will be compared to previous scans for quality assessment. The study includes safety monitoring and clinical interpretation of scans, with results shared with referring physicians. Participation involves a single PET/CT scan session lasting about 20-30 minutes, with additional dynamic imaging for some patients.

This research evaluates the use of 18F-PSMA-1007 PET/CT imaging in adult men with prostate cancer, specifically focusing on those with a history of radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or high-risk features for metastatic disease. The study is a two-center, prospective phase III cohort trial designed to assess the safety of the 18F-PSMA-1007 tracer and its ability to detect non-specific bone lesions. Participants include adults aged 18 and older with varying prostate cancer treatment histories and serum PSA levels indicating potential disease progression. Participants receive an intravenous injection of the investigational 18F-PSMA-1007 tracer followed by PET/CT imaging. The study monitors safety immediately after injection, approximately 2.5 hours post-injection after the scan, and through a self-reporting period for delayed adverse events up to 7 days later. Non-specific bone lesions identified during imaging are recorded for location and activity, with a follow-up evaluation at least one year later to determine their nature using established criteria. Throughout the trial, participants undergo monitoring for adverse effects at multiple time points and provide information for delayed safety assessments. Lesions detected are carefully documented and reassessed after one year for accuracy in distinguishing benign from malignant lesions. The total participation involves immediate post-injection observation, imaging, and long-term lesion follow-up to ensure thorough evaluation of safety and diagnostic value.

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.

This research focuses on patients with heart failure who are undergoing implantation of a left ventricular assist device (LVAD), a mechanical pump used to support the left ventricle when it cannot effectively pump blood. The study aims to analyze three-dimensional images of the right ventricle obtained through transesophageal echocardiography (TEE) during LVAD implantation, to better understand right ventricular function. Since right ventricular failure occurs in 20-50% of LVAD patients and is linked to complications, more accurate imaging methods are needed to predict risks after surgery. The study involves patients receiving one of three types of left-sided LVADs: HeartMate III, HeartWare HVAD, or Levitronix CentriMag. During the LVAD implantation procedure, 3D TEE imaging will be performed to capture detailed views of the right ventricle. These images will be used to assess various measures of right and left ventricular function, such as ventricular strain, volumes, ejection fractions, and tricuspid annular plane systolic excursion within 24 hours after the procedure. Participants will undergo TEE imaging as part of their surgery and have multiple heart function measurements recorded. Researchers will analyze these images and data to evaluate right ventricular performance and identify patients at higher risk of right ventricular failure within 14 days of LVAD implantation. The study monitors heart function closely with advanced imaging techniques to improve understanding and outcomes for patients receiving LVADs.

Researchers are evaluating the safety and diagnostic accuracy of a new imaging tracer called 68Ga-HA-DOTATATE for patients who have or are suspected to have somatostatin receptor positive tumors, including various neuroendocrine tumors. This phase II study is conducted at a single center and plans to include up to 600 scans over six years, involving both children and adults. The study aims to improve upon previous imaging methods by providing better image quality and diagnostic effectiveness compared to earlier tracers and standard CT or MRI scans. During the study, participants will receive an injection of the 68Ga-HA-DOTATATE tracer followed by PET/CT imaging. This procedure is performed at the Nuclear Medicine department at the University of Alberta Hospital. Participants may have more than one scan during the study period. The researchers will monitor safety by recording any adverse events during the imaging visits. Participants will undergo standard clinical CT or MRI scans within six months before enrollment to compare results. Researchers will evaluate the accuracy of the new tracer by comparing it to CT/MRI findings and assessing clinical outcomes over a one-year follow-up period. The main outcomes measured are the sensitivity and specificity of the imaging one year after the scan. Participants are monitored closely for safety and diagnostic effectiveness throughout their involvement in the study, which may last for up to a year after imaging.

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

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, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating NanO2, a novel oxygen therapeutic, in patients experiencing mild respiratory distress who are at risk for needing mechanical ventilation. This Phase 1b dose escalation study aims to establish dosing guidelines to inform a later Phase 2 trial. The study focuses on patients requiring supplemental oxygen but not yet critically ill, to understand the safety and tolerability of NanO2 at different dose levels. Participants will receive one of three escalating doses of dodecafluoropentane: 0.025 mL/kg, 0.032 mL/kg, or 0.050 mL/kg. These doses are being studied to determine the maximum tolerated dose over a 28-day period. The study does not include a placebo or comparator group but focuses on safely increasing dosages in this patient population. During the study, participants will be monitored closely for safety and response to treatment. Researchers will assess the maximum tolerated dose within 28 days by tracking clinical status and oxygen requirements. Patients will have regular assessments to ensure they meet the study criteria and to observe any adverse events. The total participation time includes this 28-day monitoring period, with ongoing evaluations to establish dosing safety.