Hereditary Cancer Syndromes

Researchers are evaluating the safety and effectiveness of a new molecular probe called 18F-FAPI-YQ104, which targets fibroblast activation protein (FAP), for early tumor diagnosis. This observational study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The goal is to verify how well this probe works in detecting tumors during clinical use. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT examination to capture detailed images of tumor lesions. The study will observe the probe's uptake in tumor sites, measured by SUVmax values 60 minutes after administration. No additional treatment is given; instead, the study monitors the imaging results to assess the probe's diagnostic potential. During the study, participants will undergo PET-CT scans and other imaging tests such as CT or MRI. Researchers will evaluate the images to measure tumor activity and probe uptake. Safety assessments include checking kidney and liver function, blood counts, and monitoring for allergic reactions. The study will last from April 2025 to March 2026 and includes adults aged 18 to 75 years who have confirmed tumors and meet health criteria.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PET/CT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are evaluating the clinical use of [68Ga]Ga-FAPI-46 PET/CT imaging in patients with pancreatic or bile duct cancer. This study aims to find the best timing and scan protocol, test the repeatability of the scan results, and assess the accuracy of this imaging method to detect pancreatic cancer and monitor chemotherapy effects. The study is divided into three parts, with each participant joining only one part. In part A, participants will have one [68Ga]Ga-FAPI-46 PET/CT scan and receive two venous cannulas and one arterial cannula. Part B involves two scans with a venous cannula for each. Part C includes two scans with venous cannulas and focuses on patients eligible for neoadjuvant therapy before surgery. The study evaluates the tracer's pharmacokinetics, repeatability, and diagnostic accuracy. Participants will undergo PET/CT scans and have cannulas placed as needed. Researchers will collect blood activity measurements, plasma to blood ratios, and semi-quantitative tracer uptake data. They will assess repeatability, diagnostic accuracy, and therapy response monitoring over three months. Safety and agreement between imaging and pathology will also be evaluated during and after scans.

Researchers are conducting an open-label, multi-site, multi-cohort phase 1/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in participants with advanced solid tumors, including mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer (NSCLC). The study aims to understand how ODM-212 works alongside other treatments in these serious cancers. The trial has two parts: dose escalation and dose expansion/optimization. Participants receive ODM-212 tablets along with other anti-cancer drugs depending on their cancer type. For mesothelioma, ODM-212 is combined with ipilimumab and nivolumab given intravenously on specific schedules. For pancreatic cancer, it is combined with gemcitabine and nab-paclitaxel administered intravenously in cycles. For NSCLC with a KRAS G12C mutation, ODM-212 is combined with sotorasib taken orally daily in 21-day cycles. Participants will be closely monitored throughout the study, with evaluations of side effects, dose-limiting toxicities, and adverse events tracked on average for two years. The research team will collect tumor tissue samples, monitor treatment adherence, and perform assessments to measure disease status and treatment effects. Safety will be carefully checked with exams, ECGs, and laboratory tests. The study is planned to continue through 2029, with ongoing visits and follow-ups as part of participant involvement.

Researchers are evaluating the safety and effectiveness of a combination treatment using TQB2916 injection with gemcitabine and albumin-paclitaxel as the first-line therapy for adults with metastatic pancreatic cancer. This study is a Phase II clinical trial designed to assess this new treatment approach in patients who have not received prior systemic anti-tumor therapy. The trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., and focuses on improving outcomes in this advanced cancer. The treatment involves giving TQB2916 injection combined with chemotherapy drugs, gemcitabine and albumin-paclitaxel, in 28-day cycles. Patients receive this combination as their initial therapy for metastatic pancreatic cancer. The study does not include a comparison or placebo group and uses an open-label design where both patients and researchers know the treatment being given. Participants will be monitored for up to 12 months to evaluate various outcomes including the rate of progression-free survival at 6 months, objective remission, disease control, event-free survival, overall survival, duration of response, adverse events, and immune response. Assessments will include clinical evaluations and safety monitoring throughout the study period. The goal is to gather comprehensive data on the treatment’s effects and safety profile during and after the treatment cycles.

Researchers are exploring and comparing how patients perceive sounds after receiving either cochlear implants or gene therapy for congenital deafness. This study aims to understand differences in speech perception in various environments, music appreciation, and directional hearing between these two treatments. By assessing cognitive and psychological factors alongside auditory development, the study hopes to inform better rehabilitation plans for gene therapy patients. The study includes two groups of congenital deafness patients: those who have cochlear implants and those who have undergone gene therapy for autosomal recessive deafness 9 (DFNB9). Patients receive standard postoperative care and follow-up. The evaluation covers multiple aspects such as speech perception in quiet and noisy settings, cognitive function, psychological status, and auditory cortex growth over time. Participants will be assessed before treatment and at weeks 13, 26, and 52 after intervention. Evaluations include tests of auditory speech perception, cognitive abilities, psychological health, and brain development related to hearing. The study requires participants and their guardians to provide informed consent and cooperate with follow-up visits. Healthy individuals with normal hearing are also included as controls. The goal is to compare outcomes between the two treatments over one year.

Researchers are evaluating a new treatment approach using intratumoral diffusing alpha radiation emitter devices for advanced pancreatic cancer. This prospective, interventional, open-label, single-arm, multicenter study aims to assess the feasibility and safety of these DaRT seeds in patients with locally advanced or metastatic pancreatic adenocarcinoma who have received chemotherapy or are medically unfit for it, and whose tumors are not suitable for surgery or who refuse surgery. The treatment involves the insertion of radioactive DaRT seeds directly into the tumor. These seeds release short-lived alpha-emitting atoms inside the tumor. The study includes a screening period, a procedure visit for DaRT seed insertion, an acute follow-up phase lasting 4 to 8 weeks, and a long-term follow-up phase of 3 months after insertion. A total of 15 patients will be enrolled and monitored throughout these phases. Participants will undergo evaluations including safety monitoring for adverse events up to 3 months, and assessments of treatment feasibility based on seed placement. Researchers will also measure efficacy outcomes at 1 month and 3 months after insertion and immediately following the procedure. The total participation duration is about 3 months from the time of DaRT insertion, with close follow-up to track treatment effects and patient safety.

Researchers are evaluating a multimodal artificial intelligence (AI) model for the early detection of cancer-associated cachexia in patients with pancreatic cancer. This observational study also aims to assess how feasible and acceptable diet and exercise interventions are for managing cachexia. The study will analyze both retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center. Participants include patients with newly diagnosed pancreatic adenocarcinoma at various stages, along with oncology clinicians involved in their care. The study involves baseline lifestyle and symptom assessments using dietary questionnaires, quality of life and symptom surveys, physical activity surveys, functional fitness tests, DEXA scans, and blood draws. Extended monitoring includes wearable devices such as Fitbit, diet and activity preference surveys at 9 months, and a one-time survey to assess the integration of diet and exercise into clinical practice. During the study, participants will complete surveys and wear activity monitors for up to 9 months to track quality of life, physical activity changes, and adherence to wearable devices. Researchers will evaluate the AI model's performance and survey completion rates. The study also monitors physical fitness and health status through tests and questionnaires to better understand cachexia management. This involvement helps gather comprehensive data on patient health and the practicality of lifestyle interventions in pancreatic cancer care.

Researchers are studying patients who have cancer or may be at risk of developing cancer to improve the standard of care. This observational study collects blood, tissue, and other biological samples along with associated data such as surveys, medical records, and cancer registry information. The goal is to enable new clinical trials, technology advancements, and personalized medicine for cancer patients over time. Participants provide consent to allow collection and storage of their biological samples and data. This includes blood and tissue samples as well as survey assessments and medical chart reviews. The study does not involve treatment but focuses on gathering information to support cancer research and care improvements. During the study, patients' biological samples and data are collected and stored long-term. Researchers analyze survey responses, medical records, and biological specimens to measure outcomes related to improving cancer care standards. The study follows participants for up to 20 years, aiming for a lifetime partnership to support ongoing cancer research and care advancements.