Multiple Endocrine Neoplasia (MEN)

This trial studies neuroendocrine tumors, paraganglioma, pheochromocytoma, and other SSTR-positive tumors that are not currently approved for lutetium therapy called LUTATHERA. It aims to evaluate the effectiveness and safety of a similar treatment called lutetium 177Lu edotreotide or 177Lu-DOTATOC in patients who have these diseases but are outside the standard indications for LUTATHERA. The study focuses on expanding knowledge about this therapys role in controlling disease and managing side effects. Participants receive treatment with 177Lu-DOTATOC given by slow intravenous infusion over 30 minutes using a pump system. The dose depends on patient risk factors those with fewer than two risk factors receive 7.4 GBq per cycle, while those with two or more risk factors receive 5.5 GBq per cycle. Each participant will receive 4 cycles of treatment. Risk factors include kidney impairment, previous toxicities, uncontrolled diabetes or hypertension, prior therapies, and disease burden. During the study, participants will have regular assessments over several months, including scans to measure disease control at 32 months and ongoing monitoring up to 44 months for progression-free survival, overall survival, safety, and quality of life. Researchers will check blood tests, organ function, and side effects. This non-randomized phase 2 study allows patients with measurable or evaluable disease and progressive tumors confirmed by imaging to be included, with follow-up to evaluate response and safety.

Researchers are studying whether adjusting the dose of Lutetium-177 DOTATATE Lutathera based on individual dosimetry improves treatment results for adults with unresectable neuroendocrine tumors. This randomized controlled trial compares the standard fixed dose with a customized dosing approach guided by tumor and organ uptake, aiming to evaluate if personalized treatment can enhance outcomes. The study is sponsored by the University of Iowa and involves patients with well-differentiated gastroenteropancreatic neuroendocrine tumors. Participants will receive Lutathera through an intravenous infusion every 8 weeks for up to four cycles. The first dose is fixed at 200 millicuries for all participants. Those in the investigational group may receive higher doses up to 400 millicuries in subsequent cycles based on dosimetry imaging that tracks radiation exposure to tumors, kidneys, and bone marrow. The standard group continues with 200 millicuries per cycle. Imaging such as SPECTCT scans and blood tests are performed to monitor the distribution and effects of the treatment. During the study, participants will undergo PETCT scans before treatment, blood tests for several weeks after each Lutathera dose, and complete questionnaires about their health and symptoms. Follow-up visits occur about every 8 weeks during treatment and at 2, 3, 6, and 12 months after the last cycle. Long-term monitoring continues to assess side effects and treatment outcomes, including CT scans at 6 months and lifelong follow-up for radiation-related effects. The main outcome measure is the tumor response rate 6 months after treatment.

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 optimization of 18F-DOPA PETCT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinsons disease or Lewy body dementia. The study aims to improve image quality using a new digital PETCT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PETCT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

Researchers are studying the use of 18F-metafluorobenzylguanidine 18F-MFBG positron emission tomography PET to evaluate neuroendocrine tumors, mainly pheochromocytoma, paraganglioma PPGL, and neuroblastoma NB. These tumors express norepinephrine transporter NET, which is targeted by imaging substances like 123I131I-MIBG. However, current imaging methods have limitations such as low resolution and long waiting times, which affect diagnosis. This study aims to assess the safety, image quality, diagnostic accuracy, and tumor burden detection of 18F-MFBG PET in these neural crest tumors.

Researchers are evaluating the safety and sensitivity of a new imaging agent called 61Cu-NODAGA-LM3 compared to the standard 68Ga-DOTATOC for PETCT scans in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors NET. These tumors arise from neuroendocrine cells, often grow slowly, and may be metastatic at diagnosis. The study aims to improve diagnostic accuracy using this novel radiolabeled somatostatin receptor antagonist, which may offer advantages such as longer half-life and better tumor imaging contrast. Participants will receive a single intravenous dose of 61Cu-NODAGA-LM3 followed by up to three PETCT scans. They will be randomly assigned to have the 61Cu-NODAGA-LM3 PETCT either before or after their routine 68Ga-DOTATOC PETCT, which is part of standard care. This open-label, randomized, controlled study takes place at one center and compares these two imaging approaches within a 24-hour to 4-week window. During the study, safety is monitored by tracking adverse events up to 18 hours after injection. Researchers will assess the sensitivity of 61Cu-NODAGA-LM3 imaging one hour after injection and evaluate various measures including tumor uptake, biodistribution, and patient preferences. Blood samples will be collected at multiple time points to study drug concentration and clearance. The total study duration spans from baseline assessments through imaging and follow-up, helping to understand the potential of 61Cu-NODAGA-LM3 in managing neuroendocrine tumors.

Researchers are evaluating the safety and diagnostic accuracy of 68Ga-HA-DOTATATE PETCT imaging for patients with known or suspected somatostatin receptor positive tumors, such as gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others. This phase II, single-center, non-randomized study aims to assess this new tracer produced at the Edmonton Radiopharmaceutical Centre, comparing it to standard CT or MRI imaging over a one-year follow-up period. Participants will receive a single intravenous dose of 68Ga-HA-DOTATATE at 2.64 MBqkg, with a minimum of 37 MBq and maximum of 250 MBq, followed by PETCT scanning. Up to 600 scans will be performed over six years, including both adult and pediatric patients. Some patients may undergo multiple scans during the study. Safety will be monitored immediately after injection, post-scan, and at 10 days, while efficacy will be evaluated by comparing imaging results to clinical follow-up. During the study, participants will undergo PETCT scans and standard clinical CT or MRI within six months before enrollment. Adverse events will be tracked closely in the Nuclear Medicine department, and diagnostic accuracy will be assessed through sensitivity and specificity measures at one year post-scan. The study duration allows for comprehensive safety and efficacy evaluations, helping to inform clinical care for patients with these tumors.

Neuroendocrine neoplasms NENs are rare cancers found in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other body areas. These cancers often have a high risk of returning and a low chance of survival. This trial is a Phase I study to test a new drug called ADCT-701 in adults with NENs, malignant adrenocortical carcinoma ACC, or malignant peripheral nerve sheath tumors MPNST. The study aims to find the maximum tolerated dose of ADCT-701 and evaluate its safety and preliminary anti-tumor activity. Participants will receive ADCT-701 as an intravenous infusion once every 21 days in treatment cycles. The drug dose will be gradually increased to find the best dose while monitoring for side effects. During the first two cycles, participants will visit the clinic 10 times, with fewer visits in later cycles. Treatment may continue for up to two years. After treatment ends, follow-up visits will occur four times over four months, then every nine weeks, continuing for up to five years from the start of treatment. Throughout the study, participants will undergo physical exams, blood and urine tests, imaging scans, heart function tests, and activity assessments. A tumor biopsy may be required. Researchers will monitor participants health, treatment effects, and side effects closely. The primary outcome is determining the maximum tolerated dose during the first treatment cycle. Safety, drug effects, and immune responses will be tracked for up to five years.

Researchers are studying CHM-2101, an autologous CDH17 CAR T-cell therapy, in a Phase 12 open-label trial for patients with advanced gastrointestinal cancers that have returned or not responded to at least one standard treatment in metastatic or locally advanced stages. The study aims to evaluate the safety and effects of this therapy in treating gastric adenocarcinoma, colorectal cancer, and certain neuroendocrine tumors. It is sponsored by Chimeric Therapeutics and focuses on patients who have undergone prior treatments. The trial includes two parts Phase 1 with dose escalation and expansion, and Phase 2. Participants first provide consent and undergo screening before leukapheresis, a procedure to collect immune cells for manufacturing the CHM-2101 therapy. After cell collection, participants may receive bridging chemotherapy to maintain disease stability if needed. Treatment involves three daily intravenous doses of fludarabine and cyclophosphamide followed by a single intravenous infusion of CHM-2101. The dose in Phase 1 follows a 33 escalation design to determine the recommended dose for Phase 2. Participants will be monitored for up to 18 months or until their disease progresses. Assessments include safety evaluations focusing on dose-limiting toxicities, cytokine release syndrome, adverse events, and objective tumor response. Secondary outcomes include disease control, response duration, and survival measures. Laboratory tests, imaging, and clinical evaluations will be used to follow participants health and treatment effects throughout the study.

Researchers are evaluating the safety and efficacy of 225AcAc-DOTATATE in adults with inoperable, locally advanced or metastatic, progressive, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine neoplasms. This phase I study includes patients who are either new to peptide receptor radionuclide therapy PRRT or have previously received it. The study aims to find a suitable dose and understand the treatments tolerability. Participants receive 225AcAc-DOTATATE infusions every 8 weeks for up to four cycles. The dose escalation phase has two groups one with patients who had prior 177Lu-PRRT treatment and one without. Dose levels range from 90 kBqkg to 120 kBqkg per cycle. Following this, a dose expansion phase groups patients based on their Ki-67 index, a marker of tumor growth. During the study, participants undergo regular assessments including imaging to measure tumor sites, blood tests to monitor organ function and bone marrow capacity, and evaluations of symptoms and side effects. Researchers will measure safety and tolerability up to 32 weeks after the first infusion and determine the recommended dose within 56 days. Additionally, tumor response and disease progression will be tracked for up to 24 months after the last dose. Participants are monitored closely throughout to ensure safety and collect detailed data on treatment effects.