Biliary Tract Disease

Researchers are evaluating the use of a new PET imaging tracer called [18F]FAPI-74 to detect various types of cancer. This tracer targets fibroblast-activation protein (FAP), which is found in high amounts in cancer-associated fibroblasts present in many tumors. The study aims to compare [18F]FAPI-74 PET imaging to the standard imaging tracer 18F-fluorodeoxyglucose (18F-FDG) and other standard imaging methods like CT and MRI in people with cancers such as pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytoma/paraganglioma, small cell lung cancer, extrapulmonary neuroendocrine cancer, mesothelioma, and sarcoma. Participants will receive an intravenous dose of [18F]FAPI-74 before undergoing PET/CT imaging. Each participant will have two baseline scans: one with [18F]FAPI-74 and one with the standard 18F-FDG tracer, done within one week of each other. If the initial [18F]FAPI-74 scan shows tumors, further scans with this tracer will be done at times corresponding to routine cancer restaging. If the tumors are also detected by 18F-FDG, repeat scans with this tracer will be scheduled within the same week as the repeated [18F]FAPI-74 scan. Participants with negative baseline scans will not have repeated scans but will remain in follow-up. During the study, participants will be monitored with scans and follow-up calls for up to two years to assess cancer progression and survival. Researchers will measure outcomes such as the average number of lesions at baseline, after treatment, and if cancer recurs. The study includes safety monitoring with regular assessments and imaging to detect changes or progression of disease over time.

Researchers are evaluating the use of the fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) in PET imaging to help diagnose liver cancer and assess how far it has spread before patients undergo surgery or liver transplant. This phase 1 trial focuses on patients with suspected hepatocellular carcinoma (HCC) or other liver tumors scheduled for liver resection or orthotopic liver transplant (OLT). The study compares 18F-FSPG PET/CT with other imaging methods like standard MRI, 11C-acetate PET/CT, and 18F-FDG PET/CT, and explores its uptake in benign and malignant liver lesions. Participants undergo PET scans using 18F-FSPG and either 11C-acetate or 18F-FDG within 4 weeks before surgery or OLT. The procedures include PET imaging with these radiotracers and correlative laboratory biomarker analysis. The study compares imaging results with pathology findings after surgery, assessing tumor characteristics and metabolic activity. These imaging tests aim to evaluate and compare how well 18F-FSPG PET detects liver cancer and differentiates between tumor types. During the study, researchers measure uptake values from PET scans, number of lesions, and diagnostic accuracy compared to pathology results over up to 4 years. Participants complete conventional imaging and staging with MRI or CT before PET imaging. The study tracks tumor grade, immunohistochemistry, and pharmacokinetics of the radiotracers. Safety and diagnostic measures are monitored throughout, with evaluations done within 4 weeks before surgery and continued through study completion.

Researchers are evaluating the diagnostic usefulness of a new protein-specific imaging probe called 18F-T2 in PET/CT scans for participants with solid tumors that may express high levels of the CAIX protein. This trial also aims to assess the safety, tolerability, and radiation exposure from using 18F-T2. The study includes various types of cancers such as renal cell, urothelial, colorectal, cervical, ovarian, head and neck, liver, bile duct, lung, breast, pancreatic, endometrial cancers, and Von Hippel Lindau Disease. Participants will receive an intravenous injection of 18F-T2 at a dose of 0.05-0.10 mCi/kg. About 60 minutes after the injection, they will undergo combined CT and PET imaging sessions to evaluate tumor detection using this new probe. The study focuses on measuring the diagnostic sensitivity and specificity of 18F-T2 PET/CT and monitoring adverse events shortly after injection. During the study, participants will be closely monitored for side effects within 24 hours of receiving the injection. Researchers will collect imaging data from the PET/CT scans and assess diagnostic accuracy up to one month after study completion. Participants must provide informed consent and comply with all study requirements throughout their involvement. The total duration and follow-up involve safety and diagnostic performance evaluation after the imaging procedure.

Researchers are evaluating the use of [68Ga]Ga-FAPI-46 PET/CT imaging in patients with pancreatic or bile duct cancer to improve detection and monitoring of tumor lesions. The study focuses on three parts: determining the best timing and scan protocol, assessing repeatability of the scan results, and evaluating the accuracy of the scan in detecting cancer and monitoring chemotherapy response. Pancreaticobiliary cancers have a poor outlook, and better imaging methods could help guide treatment decisions and avoid unnecessary surgery. Participants will undergo one or two [68Ga]Ga-FAPI-46 PET/CT scans depending on the study part. In part A, patients have one scan with placement of two venous cannulas and one arterial cannula. In parts B and C, patients receive two scans each with venous cannula placement before scanning. The scans use a tracer targeting fibroblast activation protein to identify cancer tissue more accurately than conventional imaging. During the study, participants will have blood activity and plasma-to-blood ratio measurements of the tracer taken, along with semi-quantitative assessments of tracer uptake. Researchers will measure repeatability, diagnostic accuracy, and therapy response monitoring over a three-month period. The study includes safety monitoring and requires adherence to protocol procedures throughout participation.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore possible links to certain diseases. This multicenter, prospective, non-interventional study plans to enroll around 12,000 adults over 36 months. The goal is to create a pilot map of HLA genetic variation to support medical research and potential clinical uses, including evaluating connections with various health conditions such as respiratory, cardiovascular, metabolic, neurological, psychiatric, gastrointestinal, hematologic, rheumatologic diseases, and chronic renal failure. During the study, participants will visit a participating site once to provide demographic information, lifestyle habits, medical history, and recent clinical lab test results if available. Two buccal swabs will be collected from each participant for DNA extraction and HLA genotyping analysis. Selected samples will also undergo full low-pass whole genome sequencing to further study associations between the HLA region and autoimmune diseases. After analysis, participants can securely access a personalized ancestry report if they wish. Participants will be asked about their health, lifestyle, and medical treatments, and provide samples for genetic testing. Researchers will monitor the allele frequency of HLA alleles at the Greek population level over 36 months. The study includes secure data handling and offers long-term follow-up through genetic and ancestry reports. This comprehensive approach aims to enhance understanding of genetic variation and its possible disease correlations in Greece.

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

This research aims to systematically explore the long-term changes in liver function, metabolic state, immune response, and other physiological aspects in children after biliary tract reconstruction. It also evaluates how these changes may influence the risk of chronic diseases such as cardiovascular diseases, diabetes, liver cirrhosis, and their effects on cognitive function and musculoskeletal health during adulthood. The study seeks to identify potential biomarkers that could predict future health outcomes and proposes preventive and intervention strategies to reduce long-term complications. The study involves observing children who have undergone biliary tract reconstruction and comparing them with healthy children matched by age and gender who serve as the control group. There are no specific treatment interventions described, as this is an observational study focusing on long-term physiological changes after surgery. Participants will be monitored over several years with evaluations including targeted metabolic component detection in feces and plasma. These assessments occur at baseline (before surgery) and at multiple time points after surgery: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years. Researchers will track changes in metabolic markers and physiological functions to better understand the impacts of early changes on long-term health.

Severe obstructive jaundice caused by pancreatic head cancer often requires preoperative biliary drainage, but the best approach and timing remain unclear. This study compares a new drainage strategy using serum prealbumin levels as the main guide against the traditional method based on serum total bilirubin. It is a randomized, controlled, multicenter prospective study focused on patients with resectable pancreatic head cancer and severe obstructive jaundice, aiming to improve clinical decisions on drainage and surgery timing. Participants will be assigned to either the modified preoperative biliary drainage strategy guided by serum prealbumin or the traditional strategy guided by serum total bilirubin. Both groups will undergo endoscopic biliary drainage before planned radical pancreaticoduodenectomy surgery. The study evaluates how these different strategies affect patient outcomes and surgical timing. During hospitalization and up to three months after, researchers will monitor in-hospital complications and overall patient prognosis. Participants will be assessed through lab tests including prealbumin and bilirubin levels, clinical evaluations, and surgical follow-up. The study aims to provide strong evidence to guide preoperative biliary drainage practices for pancreatic head cancer patients.

Gastrointestinal cancers such as hepatocellular carcinoma, cholangiocarcinoma, pancreatic ductal adenocarcinoma, esophageal squamous cell carcinoma, gastric cancer, and colorectal cancer pose a significant global health challenge due to the lack of effective early screening methods. Current diagnostic tools are often invasive, expensive, or insufficiently sensitive to detect early-stage disease, leading to many diagnoses at advanced stages with limited treatment options. Researchers are investigating circulating microRNAs (miRNAs) as a promising noninvasive alternative to identify cancer-related molecular changes in blood samples. This research involves creating and analyzing a large, international collection of stored blood samples from patients with various gastrointestinal cancers and non-cancer controls. Using small RNA sequencing, the study will generate detailed miRNA profiles and apply machine learning techniques to select a precise panel of miRNAs that can distinguish cancer patients from non-cancer individuals. The study will also test the panel's ability to differentiate among specific types of gastrointestinal cancers across diverse populations and clinical settings. Participants contribute retrospective blood samples and clinical data for analysis. The study assesses the accuracy of the miRNA panel in detecting cancers before treatment by measuring diagnostic performance metrics like sensitivity and specificity. This work aims to develop a reliable, scalable, and cost-effective blood test to support early detection and screening of multiple gastrointestinal cancers, potentially improving patient outcomes worldwide.

Frailty is a common condition in older adults that can increase the risk of poor health outcomes like falls, hospitalization, and death. This research evaluates a personalized approach that uses a frailty assessment to help patients over 65 make informed decisions about having a surveillance colonoscopy. The study compares this tailored method to the current standard care to see how it affects patient satisfaction and the number of colonoscopies avoided. Participants at the Princess Alexandra Hospital will be randomly assigned to one of two groups. One group will receive a personalized approach that includes a frailty assessment and structured information to support decision-making. The other group will receive the usual standard care without this additional assessment. This comparison aims to see if the personalized method helps patients and doctors better weigh the risks and benefits of surveillance colonoscopies. During the study, researchers will measure patient satisfaction using various questionnaires at different times, including immediately and a few weeks after the colonoscopy procedure. They will also track how many patients decide not to have a surveillance colonoscopy based on the information provided. The study focuses on engaging both patients and clinicians to improve decision-making and reduce unnecessary procedures while monitoring safety and outcomes closely.