Digestive System Neoplasm

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

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 studying how the duration of oxaliplatin infusion affects nerve damage in patients with gastrointestinal cancers. This phase II trial compares giving oxaliplatin over 2 hours versus 6 hours to see if a longer infusion can reduce or delay nerve damage, which may allow patients to stay on standard chemotherapy doses longer without delays. The European Organization for Research and Treatment of Cancer's patient-reported neuropathy scale (CIPN-20) is used to measure nerve damage severity. Participants are randomly assigned to one of two groups: one receives oxaliplatin and leucovorin intravenously over 2 hours along with fluorouracil given in two doses (a quick low dose and a continuous higher dose) on day 1; the other receives oxaliplatin over 6 hours with leucovorin and fluorouracil as in the first group. Treatments are repeated every 14 days unless disease progresses or side effects are unacceptable. After treatment, patients are followed up at 1, 3, 6, 12, and 18 months. Throughout the study, patients undergo evaluations including measurements of nerve damage using the CIPN-20 scale, pharmacokinetic tests to assess drug concentration and clearance, tumor size monitoring, and records of therapy duration, dose adjustments, and treatment delays. These assessments help researchers understand how infusion time affects nerve damage severity and overall treatment delivery. The total participation duration includes the treatment period and up to 18 months of follow-up.

Researchers are investigating the safety and effectiveness of 5 years of adjuvant imatinib treatment in patients with gastrointestinal stromal tumors (GIST) who have a high risk of recurrence. This includes patients with tumor rupture defined by Nishida classification or those with tumors 10cm or larger and a high mitotic index. The study builds on previous findings that showed benefits of shorter imatinib treatment durations and aims to improve long-term outcomes for high-risk patients. Participants will receive imatinib mesylate orally at a dose of 400 mg once daily for 5 years. This treatment extends the current standard 3-year adjuvant therapy by an additional 2 years. The study focuses on patients who have had complete surgical removal of their tumor and meet specific high-risk criteria. The trial is a phase 2, open-label study without randomization or placebo. Throughout the 5-year treatment period, participants will be monitored for progression-free survival as the primary outcome. Researchers will assess tumor status and overall health through regular visits and laboratory tests to evaluate safety and response. The study will also monitor organ function and patient performance status to ensure ongoing suitability for treatment. Participation may last up to 5 years, including follow-ups to observe long-term effects of the therapy.

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.

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a diverse group of tumors arising from endocrine cells in the digestive tract. Researchers are evaluating the use of 68Ga-DOTATOC PET imaging, combined with MRI or CT scans, to improve diagnosis and prognosis for patients with GEP-NETs. This study focuses on assessing the accuracy and predictive value of these imaging techniques over a period of 10 years. Patients who qualify will undergo 68Ga-DOTATOC PET as part of their standard diagnostic process. This PET scan may be performed with MRI or CT, with PET/MRI conducted on a 3.0T time-of-flight scanner approximately 60 minutes after injection of the tracer. The study will include patients during their regular clinical evaluation without additional experimental treatments. Participants will be monitored through their imaging results collected during routine care. The main outcome measured is the diagnostic accuracy of the imaging over 10 years. The study aims to gather important information on how these imaging methods can predict disease progression and mortality while minimizing radiation exposure, especially with the use of PET/MRI. Participants give informed consent and receive imaging based on clinical need throughout their follow-up.

Researchers are evaluating the effectiveness of 68Ga-HA-DOTATATE PET/CT imaging to diagnose somatostatin-positive neuroendocrine tumors compared to conventional imaging methods such as CT, MRI, 111 In-pentetreotide scans, and 18F-FDG PET/CT. The study aims to assess the usefulness of 68Ga-HA-DOTATATE in initial diagnosis, surveillance of completely removed tumors, and localization of functioning tumors like insulinoma and gastrinoma. Participants will receive an intravenous injection of 100-250 MBq of 68Ga-HA-DOTATATE. Imaging starts 45-90 minutes after the injection, followed by a CT scan for localization without moving the patient. The 68Ga-HA-DOTATATE PET/CT results will be compared to any prior imaging and pathology reports to evaluate its diagnostic utility. During the study, participants will undergo the PET/CT imaging procedure and provide informed consent. The research team will monitor the imaging results over five years to assess the diagnostic value of 68Ga-HA-DOTATATE PET/CT. Participants are expected to comply with study instructions and attend scheduled imaging sessions as part of this observational study.

Researchers are studying a new type of scan called FAPI-PET/CT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PET/CT scan, where a small amount of [18F]-FAPI-74 is given intravenously about 60 minutes before a PET/CT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

Researchers are studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.

Researchers are studying a new cancer treatment called [212Pb]VMT-Alpha-NET for tumors that have somatostatin receptors (SSTRs) on their surface. These tumors include those found in the lungs, head and neck, digestive tract, kidneys, and adrenal glands. The study focuses on people with tumors that have spread and cannot be removed by surgery. The goal is to find the highest safe dose of this drug and evaluate its safety and effects on these cancers. The treatment involves giving [212Pb]VMT-Alpha-NET through a vein on the first day of each 8-week cycle, for a total of four cycles. Some participants will also receive a related imaging drug, [203Pb]VMT-Alpha-NET, a few days before the first two cycles to track where the drug travels in the body using scans. After each dose, participants will stay in the hospital for a few nights and have weekly blood tests during each cycle. Participants will have physical exams, blood and urine tests, heart function tests, and imaging scans before and during the study. Researchers will monitor safety, drug effects, and tumor response through scans, lab tests, and questionnaires. Follow-up visits will continue for up to six years after the last treatment to check on long-term outcomes and overall health.