Ongoing Clinical Trials for Small Intestine Neuroendocrine Tumours
There are currently 3 clinical trials investigating new approaches to diagnosis, treatment, and monitoring for patients with small intestine neuroendocrine tumours. These studies are being conducted across several European countries including Denmark, France, Germany, and Spain, focusing on advanced imaging techniques and targeted radiation therapies to improve patient outcomes and quality of life.
Clinical trial locations
- Denmark
- France
- Germany
- Spain
Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
This study, conducted in Denmark, focuses on developing better ways to predict how long patients with neuroendocrine neoplasms might remain stable before their disease progresses. The research uses two different imaging substances to create detailed pictures of tumours using PET/CT scanning technology.
Main inclusion criteria: Participants must be between 18 and 65 years of age with a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm through tissue examination or evidence of tumour spread suggesting this type of cancer. Patients must have a WHO Performance status of 0-2, meaning they can perform at least light activities. All participants must be able to read and understand patient information and provide informed consent.
Main exclusion criteria: The study excludes patients who are unable to undergo PET/CT scanning, have known allergies to the imaging agents being used, are pregnant or breastfeeding, or have severe claustrophobia that would prevent scanning. Patients with metal implants that could interfere with imaging, those who cannot lie still for 30-45 minutes during scanning, or those with a history of other active cancers in the past 5 years are also excluded.
Study focus: The trial aims to develop predictive models for disease progression by analyzing measurements from combined scans using both 64Cu-DOTATATE and 18F-FDG. Participants will receive both imaging solutions on the same day and undergo two separate PET/CT scans. Their health status will be monitored until December 31, 2026, to track progression-free survival and overall survival.
Investigational substances: 64Cu-DOTATATE is a radioactive tracer that specifically binds to receptors commonly found on neuroendocrine tumours, helping visualize their location throughout the body. 18F-FDG is another radioactive tracer that shows areas of high glucose consumption, which is common in fast-growing cancer cells. Together, these imaging agents provide complementary information about tumour characteristics and behaviour.
Study on Reducing Side Effects of Lutetium (177Lu) Oxodotreotide in Patients with Advanced Midgut Neuroendocrine Tumors
This clinical trial, being conducted in France and Spain, investigates whether extending the interval between treatments with Lu177-Dotatate can reduce blood-related side effects while still effectively managing advanced midgut neuroendocrine tumours. The study focuses on tumours originating in parts of the small intestine and right side of the colon.
Main inclusion criteria: Patients must be 18 years or older with confirmed unresectable, advanced, or metastatic midgut neuroendocrine tumours. They must have recovered to Grade 1 or lower from previous treatment side effects and have a life expectancy of at least 12 months. The Ki-67 index must be 20% or lower, and the disease must have shown progression within 36 months before joining. All tumour lesions must be somatostatin receptor positive in imaging tests, and patients must have measurable disease. Both female and male participants must agree to use effective birth control during the study and for 7 months after the last treatment.
Main exclusion criteria: Patients with neuroendocrine tumours not originating from the midgut, those with fast-growing forms of the disease, pregnant or breastfeeding women, and those with severe health conditions that could interfere with study treatment are excluded. Patients who have previously received any type of radioligand therapy cannot participate.
Study focus: The primary goal is to determine whether administering Lu177-Dotatate every 16 weeks instead of every 8 weeks can reduce blood-related toxicity while maintaining treatment effectiveness. Participants will undergo regular assessments including blood tests and imaging studies to monitor tumour response. The study will track side effects and measure outcomes over 24 months, with final data collection extending to January 31, 2029.
Investigational drug: Lu177-Dotatate is a targeted therapy that delivers radiation directly to cancer cells. It works by attaching to specific receptors on tumour cells, allowing the radioactive component to destroy cancer cells from the inside while minimizing damage to surrounding healthy tissues. This radiopharmaceutical is administered as an intravenous infusion.
Efficacy of 177Lu-DOTATATE as Adjuvant Therapy After Surgery for Stage III Small Intestinal Neuroendocrine Tumors
This German study examines whether adding peptide receptor radionuclide therapy after complete surgical removal of stage III small intestinal neuroendocrine tumours can help prevent cancer recurrence. The trial compares patients receiving this additional treatment to those who only undergo standard monitoring after surgery.
Main inclusion criteria: Participants must be 18 years or older with stage III small intestinal neuroendocrine neoplasm that has been completely removed through surgery, including examination of the entire small bowel and removal of at least 8 lymph nodes. Patients must have had a positive somatostatin receptor imaging test before surgery but a negative test after surgery, indicating no visible remaining tumour. The tumour must be classified as grade G1, G2, or G3. Women who can become pregnant must use highly effective contraception during the study and for 7 months after treatment. Men who can father children must use condoms during treatment and for 4 months afterward, and their female partners must also use effective contraception.
Main exclusion criteria: Patients with cancer that has spread beyond the local region, those who have previously received peptide receptor radionuclide therapy, and those currently receiving other cancer therapies are excluded. The study also excludes patients with a history of other cancers within the past 3 years, severe kidney or liver problems, inadequate bone marrow function, serious heart conditions, and pregnant or breastfeeding women.
Study focus: Participants are randomly assigned to either receive Lutathera 370 MBq/mL solution as an infusion or undergo standard surveillance without additional treatment. Both groups are monitored for at least 60 months to track cancer recurrence. The study includes regular imaging scans, quality of life questionnaires, and monitoring for side effects. Final data collection may extend to December 31, 2033.
Investigational therapy: Peptide Receptor Radionuclide Therapy (PRRT) using Lutetium-177 DOTATATE is a targeted treatment that delivers radiation directly to cancer cells. The medication consists of a radioactive isotope attached to a molecule that specifically binds to somatostatin receptors found on neuroendocrine tumour cells, causing DNA damage and cell death while limiting harm to healthy tissues. It is administered via intravenous infusion.
Summary
The three ongoing clinical trials for small intestine neuroendocrine tumours represent different approaches to improving patient care across the disease spectrum. One trial in Denmark focuses on advanced imaging techniques to better predict disease progression, while two trials in France, Spain, and Germany investigate targeted radiation therapies using lutetium-based compounds.
A notable pattern is the concentration of research on peptide receptor radionuclide therapy, with two of the three trials specifically examining Lu177-DOTATATE or similar compounds. One trial explores optimal treatment scheduling to minimize side effects in advanced disease, while another investigates whether this therapy can prevent cancer recurrence after surgery for earlier-stage disease. This reflects growing interest in using targeted radiation approaches for neuroendocrine tumours.
The trials are distributed across four European countries, with each study addressing distinct clinical questions relevant to different stages of disease management. Patients interested in participating should discuss eligibility criteria and practical considerations with their healthcare team, as each trial has specific requirements regarding disease stage, previous treatments, and ability to travel to study sites.
