Ongoing Clinical Trials for Pancreatic Neuroendocrine Tumour
There are currently 4 clinical trials recruiting patients with pancreatic neuroendocrine tumour. These studies are testing various approaches including advanced imaging techniques to predict disease progression, combination treatments with targeted therapies and radioactive compounds, and new drug combinations for patients whose disease has progressed despite standard treatments. The trials are taking place across several European countries including Belgium, Denmark, Germany, and the Netherlands.
Clinical trial locations
- Belgium
- Denmark
- Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
- Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
- Germany
- Netherlands
Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
This study is being conducted in Denmark and focuses on developing new ways to predict how long patients with neuroendocrine tumours might remain stable before their disease worsens. The research uses advanced imaging technology combining two different scanning methods.
Main inclusion criteria: Participants must be adults aged 18 to 65 years with a confirmed diagnosis of gastro-pancreatic neuroendocrine tumour through tissue examination, or have tumour spread suggesting this type of cancer. They must be able to read and understand patient information, provide informed consent, and have a WHO Performance status of 0-2, which measures their ability to care for themselves and perform daily activities.
Main exclusion criteria: People cannot participate if they are under 18 or over 65 years of age, are unable to undergo PET/CT scanning, have known allergies to the imaging agents, are pregnant or breastfeeding, cannot provide informed consent, have participated in another clinical trial within the past 30 days, suffer from severe claustrophobia, have metal implants that could interfere with imaging, cannot lie still for approximately 30-45 minutes during scanning, have serious medical conditions that could interfere with study participation, or have a history of other active cancers in the past 5 years.
Focus of the trial: The study aims to create predictive models for disease progression by analyzing measurements from combined PET/CT scans using two different imaging substances. Participants will receive injections of both 64Cu-DOTATATE and 18F-FDG on the same day, with separate scans performed for each substance. The results will be monitored until December 31, 2026, to track how long patients remain without disease progression.
Investigational substances: The trial uses two radioactive imaging agents. 64Cu-DOTATATE is a tracer that specifically binds to receptors commonly found on neuroendocrine tumours, helping doctors visualize where these tumours are located throughout the body. 18F-FDG is a radioactive form of glucose that accumulates in cells using large amounts of sugar, which is common in fast-growing cancer cells. Together, these tracers provide complementary information about the tumours, helping doctors understand both their location and how active they are.
Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
This Danish study tests a new imaging method that combines two different techniques to better understand how tumours use energy. The research involves patients with various types of cancer, including neuroendocrine tumours of the pancreas.
Main inclusion criteria: Participants must be adults aged 18 years or older with a confirmed diagnosis of one of four cancer types: breast cancer, neuroendocrine tumour, lymphoma, or sarcoma. The tumour must be at least 1.5 centimeters in size. Both men and women can participate, and patients must not be part of any vulnerable population groups.
Main exclusion criteria: People cannot join if they are under 18 or over 65 years old, cannot lie still in the PET/MR scanner for up to 60 minutes, have claustrophobia, have metal implants or devices not compatible with MRI, are pregnant or breastfeeding, have severe kidney dysfunction, have known allergies to the imaging substances, have received other experimental drugs within 30 days before the study, cannot provide informed consent, have uncontrolled medical conditions, weigh more than 180 kg due to scanner limitations, or have blood glucose levels above 200 mg/dL at the time of imaging.
Focus of the trial: The study aims to determine whether it is possible to perform both imaging methods simultaneously to better understand how tumours process different nutrients. This research may lead to improved ways of detecting and monitoring cancer. The imaging procedure will be performed once for each participant using a combined PET/MR scanner.
Investigational substances: The trial uses two imaging agents. Hyperpolarized [1-13C]Pyruvate is used in magnetic resonance spectroscopy to show how cancer cells process nutrients differently from normal cells. 18F-FDG is a radioactive form of glucose used in PET imaging that accumulates in cancer cells because they typically consume more glucose than healthy cells. Both substances are given through intravenous injections, allowing doctors to see tumour metabolism from two different perspectives at the same time.
Study on Continuing Somatostatin Analogues with Sunitinib, Octreotide, and Lutetium (177Lu) Oxodotreotide for Patients with Neuroendocrine Tumors
This trial is being conducted in Belgium and the Netherlands and focuses on understanding whether continuing treatment with somatostatin analogues when the disease progresses can help patients live longer without their disease getting worse. The study examines different second-line treatment approaches.
Main inclusion criteria: Participants must be at least 18 years old and provide written informed consent. They must have an ECOG performance status of 2 or less, meaning they can perform most daily activities with some limitations. Patients must have a confirmed diagnosis of locally advanced or metastatic, non-functional, well-differentiated neuroendocrine tumour that has shown radiological disease progression while on first-line treatment with somatostatin analogues. Depending on the substudy, patients must have an indication to start either targeted therapy with sunitinib or everolimus, or PRRT with 177Lu-DOTATATE as second-line therapy.
Main exclusion criteria: Patients with other types of cancer that are not neuroendocrine tumours cannot participate. Those who have not started second-line therapy, are not in the specified age range, are part of a vulnerable population, or are not willing or able to follow study procedures and visits are also excluded.
Focus of the trial: The study is divided into two parts. One examines the effects of continuing or stopping somatostatin analogues when patients start PRRT as second-line treatment. The other part looks at continuing or stopping these medications when patients start targeted therapy. The study will assess how long patients can live without disease progression, time to overall health decline, survival rates, response to treatment, quality of life, and side effects.
Investigational treatments: The trial involves several medications. Somatostatin analogues are hormone-like medications given by injection that help slow tumour growth by mimicking a natural hormone in the body. PRRT (Peptide Receptor Radionuclide Therapy) uses a small amount of radioactive material attached to a molecule that specifically targets tumour cells, delivering radiation directly to the tumour. Targeted therapy refers to medications that specifically interfere with molecules involved in cancer growth and spread while causing less harm to normal cells.
Study of Ramucirumab and Dacarbazine for Patients with Progressive Metastatic Pancreatic Neuroendocrine Tumors
This German study investigates whether a combination of two medications can help control disease in patients with pancreatic neuroendocrine tumours that have spread to other parts of the body and are continuing to grow despite treatment.
Main inclusion criteria: Participants must be between 18 and 75 years old with a confirmed diagnosis of metastatic neuroendocrine tumour of the pancreas that cannot be removed by surgery. The tumour must be measurable using specific medical criteria and must be getting worse despite treatment with certain medications (but not with DTIC or temozolomide). Previous treatments like TACE and SIRT are allowed if done at least 3 months before joining, and PRRT if done at least 12 months before. Patients must have an ECOG performance status of 0-1, meaning they are fully active or restricted only in physically strenuous activity. They must have a life expectancy of more than 12 weeks, adequate organ function, and if sexually active, must use effective birth control. Female participants who can become pregnant must have a negative pregnancy test within 7 days before starting treatment.
Main exclusion criteria: Patients with other types of cancer not related to the pancreas cannot participate. Those who have had another cancer in the past (unless treated and disease-free for at least 5 years), had a heart attack or stroke in the last 6 months, have uncontrolled high blood pressure, serious infections requiring treatment, are pregnant or breastfeeding, had major surgery within the last 4 weeks, have bleeding disorders, are currently in another clinical trial, or have known allergies to the study drugs are not eligible.
Focus of the trial: The study explores whether the combination of ramucirumab and dacarbazine can help control the disease. After six months, an evaluation will assess the disease control rate through imaging studies and other tests. The study will also look at how long patients live without disease progression, overall survival, side effects, and quality of life. Additional tests will examine proteins and markers in the blood that might predict treatment effectiveness.
Investigational drugs: Ramucirumab is given through an intravenous infusion and works by blocking a specific protein that tumours need to grow new blood vessels. By stopping the formation of these blood vessels, it can help slow down or stop tumour growth. Dacarbazine is a type of chemotherapy given by intravenous injection that interferes with the DNA of cancer cells, preventing them from growing and dividing, which helps control the spread of cancer and can reduce tumour size.
Summary
The four ongoing clinical trials for pancreatic neuroendocrine tumour reflect different research approaches to managing this disease. Two trials in Denmark focus on advanced imaging techniques to better predict disease progression and understand tumour metabolism, using novel combinations of imaging agents. These studies may help doctors identify which patients are at higher risk of disease progression and could benefit from earlier or more aggressive treatment.
The remaining two trials focus on treatment strategies. The multinational study across Belgium and the Netherlands examines whether continuing somatostatin analogues during second-line therapy provides additional benefit, while the German study tests a new combination of ramucirumab and dacarbazine for patients whose disease has progressed despite standard treatments.
Notably, Denmark is leading in imaging research with two trials, while treatment-focused studies are distributed across Belgium, Germany, and the Netherlands. The trials address different stages of disease management, from early prediction and monitoring to treatment of progressive disease. Patients interested in participating should discuss with their healthcare providers which trial might be most appropriate for their specific situation, considering factors such as disease stage, prior treatments, and geographical location.
