Pancreatitis

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 probes 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 probes 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 PETCT 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, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT 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 PETCT 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 12a 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 PETCT 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 safety, feasibility, and diagnostic accuracy of a new PET tracer called 68Ga-SorB targeting Sortilin, a receptor highly expressed in several solid tumors including melanoma, liver, lung, pancreatic, breast, and ovarian cancers. This exploratory diagnostic study compares 68Ga-SorB PETCT imaging to the standard 18F-FDG PETCT, aiming to improve tumor detection and characterization by using a more tumor-specific tracer with fewer false positives. Participants will receive a single intravenous dose of 68Ga-SorB followed by whole-body PETCT imaging about 60 minutes after injection. The study compares these imaging results with clinically indicated 18F-FDG PETCT scans done within a set timeframe. No therapeutic treatments are given as part of this study. Approximately 40 to 50 adults with confirmed or suspected tumors will be enrolled for imaging and follow-up. During the study, participants are monitored for adverse events from tracer administration until about 24 hours post-imaging. Tumor uptake is measured using quantitative PET parameters such as SUVmax and tumor-to-background ratio. Follow-up includes pathology review and clinical assessments up to 3 months after imaging to evaluate lesion detection, diagnostic sensitivity, specificity, and overall accuracy. This research will provide initial clinical evidence to support further development of Sortilin-targeted imaging and potential future therapeutic applications.

Researchers are conducting an open-label, multi-site, multi-cohort phase 12 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 expansionoptimization. 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 treatments effects and safety profile during and after the treatment cycles.

Endoscopic retrograde cholangiopancreatography ERCP is widely used to manage biliary and pancreatic diseases, but it can lead to complications ranging from mild to severe, with post-ERCP pancreatitis PEP being the most common serious adverse event. This research aims to evaluate whether combining rectal indomethacin with cold-water irrigation of the ampulla reduces the incidence of PEP compared to rectal indomethacin alone, focusing on an Indian adult population. The study also compares PEP severity, adverse effects, hospital stay duration, and protocol adherence. Participants will receive either rectal indomethacin alone or rectal indomethacin plus cold saline irrigation 4-10C, 250 mL for 2 minutes applied before ERCP. Rectal indomethacin is administered 30 to 60 minutes prior to the procedure. This is a single-center pilot randomized control superiority trial lasting 12 months with a 30-day follow-up period. The study will explore effects based on baseline PEP risk, ERCP type, and use of prophylactic pancreatic stenting. During the study, participants will be assessed for post-ERCP pancreatitis classification within 10 days, with evaluations of serum amylase and lipase, abdominal pain scores, and adverse events such as gastrointestinal bleeding, perforation, cholangitis, aspiration, and hypoxemia within 24 hours after ERCP. The study includes monitoring for feasibility, adherence, and safety through clinical evaluations and laboratory tests. Total participation includes treatment and follow-up lasting up to 30 days after the procedure.

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 models 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.

Pancreatic ductal adenocarcinoma PDAC is a deadly cancer often diagnosed late due to its silent early phase, leading to poor survival rates. Current early detection mainly relies on invasive and costly imaging methods like MRI and endoscopic ultrasound, which have limited sensitivity. This study investigates using circulating cell-free and exosome-bound microRNAs as less invasive markers to identify PDAC risk and understand disease behavior in adults at increased risk due to family history, hereditary conditions, or pancreatic cysts. The study focuses on analyzing stored plasma samples from adults 18 years and older who are at higher risk for PDAC because of familial pancreatic cancer, hereditary pancreatic cancer syndromes, or mucinous pancreatic cystic lesions. No new treatments or devices are given instead, researchers measure microRNA levels from these samples using validated laboratory techniques. The goal is to see if this combined microRNA profiling can better predict PDAC risk and progression compared to standard imaging surveillance alone. Participants have already provided plasma samples and clinical data collected during their routine medical care, which researchers will use for microRNA analysis and risk assessment. The study measures how accurately these biomarkers detect PDAC by tracking sensitivity, specificity, and overall prediction accuracy over about one year. There is no impact on clinical care, and no additional procedures are required from participants during the study period that extends until early 2032.

Researchers are studying the effects of MAR001 on adults with high triglycerides and remnant cholesterol. This phase 2, randomized, double-blind, placebo-controlled trial aims to compare MAR001 with a placebo to see how it changes triglyceride levels after eating a mixed meal. The study focuses on the postprandial after eating state in adults aged 18 to 75 years with elevated triglycerides and remnant cholesterol. Participants receive either MAR001 or a matching placebo through subcutaneous injections. The treatment period lasts 12 weeks, during which researchers measure changes in triglycerides and remnant cholesterol levels after a mixed meal. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcomes assessors do not know who receives MAR001 or placebo. During the study, participants will have fasting triglyceride tests at screening and regular assessments throughout the 12 weeks. Researchers will track the area under the curve and peak plasma concentrations of triglycerides and remnant cholesterol after meals to evaluate treatment effects. Participants must maintain stable diets and medication regimens during the trial. Safety and adherence will be monitored with ongoing assessments to understand the impact of MAR001 compared to placebo.