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Study of Intra-Arterial Infusion of Lutetium (177Lu) Oxodotreotide for Adults with Gastroenteropancreatic Neuroendocrine Tumors with Liver Metastases

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which affects the digestive system and pancreas. The study involves using a treatment called peptide receptor radionuclide therapy with a medication known as Lutathera. This treatment uses a radioactive substance to target and treat cancer cells. The trial also involves imaging techniques using 68Ga-DOTA-peptides to help visualize the tumors.

The purpose of the study is to explore the effects of delivering the treatment directly into the liver through a method called intra-arterial hepatic infusion. This approach is being tested in patients whose cancer has spread mainly to the liver. During the study, participants will receive the treatment and undergo imaging scans to assess how well the treatment is working. The study will also monitor the safety of the treatment and its effects on other organs like the kidneys and spleen.

Participants in the study will receive up to five cycles of the treatment, with the possibility of receiving a placebo in some cases. The study aims to gather information on how the treatment affects the tumors and the body, providing valuable insights into its potential benefits and risks for patients with GEP-NETs.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide a signed written informed consent.

    The patient must have a well-differentiated neuroendocrine tumor of gastrointestinal or pancreatic origin, with liver metastases that are dominant or exclusive.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the patient's eligibility, including a review of medical history and current health status.

    The patient must have adequate kidney and liver function and no significant blood disorders.

  3. Step 3

    Treatment cycle preparation

    The patient prepares for the treatment cycle, which involves the administration of Lutathera (177Lu-DOTA-peptide) through intra-arterial hepatic infusion.

    The patient must have completed four standard cycles of Lutathera prior to this study.

  4. Step 4

    Treatment administration

    The patient receives the fifth cycle of Lutathera therapy via intra-arterial hepatic infusion.

    This involves the use of radiolabeled somatostatin analogs, specifically 68Ga-DOTA-peptides and 177Lu-DOTA-peptides.

  5. Step 5

    Monitoring and evaluation

    The patient undergoes PET scans to measure the uptake of 68Ga-DOTA-peptides in liver metastases and other organs.

    The safety and efficacy of the treatment are evaluated, focusing on the liver, kidneys, spleen, and bone marrow.

  6. Step 6

    Follow-up

    The patient is monitored for any side effects or complications following the treatment.

    Contraception must be maintained for at least 7 months after the last Lutathera injection for women and at least 4 months for men with partners of childbearing potential.

Who can join the trial?

11 criteria

  • The patient must have a **well-differentiated neuroendocrine tumor** of the gastrointestinal or pancreatic origin. This means the tumor cells look somewhat like normal cells under a microscope.
  • The patient must sign a **written informed consent**. This is a document that explains the study and confirms the patient agrees to participate.
  • The patient must be part of a **social security system**. This means they have access to government-provided health services.
  • The patient must have **liver metastases** that are the main or only site of the disease. These are cancer cells that have spread to the liver. The disease must be measurable by a method called **RECIST 1.1** and cannot be removed by surgery after four treatment cycles.
  • The patient must have shown disease progression after treatment with a **cold somatostatin analog** within 12 months, or have more than 50% of the liver affected by cancer without waiting for the disease to get worse.
  • The patient must have received four standard treatment cycles of **LUTATHERA®**, a specific cancer treatment.
  • The patient must have an **ECOG performance status** of 0-2. This is a scale that measures how well the patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must have **adequate kidney and liver function**. This means their kidneys and liver are working well enough, with specific levels for creatinine clearance and liver enzymes (ALT/AST).
  • The patient must not have any blood-related issues after four cycles of LUTATHERA®. This includes having enough hemoglobin, neutrophils, and platelets, which are components of blood.
  • The patient must be **18 years or older**. There is no upper age limit.
  • Women who can have children must use **highly effective contraception** methods, and men must use condoms or ensure their partners use effective contraception. This is to prevent pregnancy during the study and for a period after the last treatment.

Who cannot join the trial?

5 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who do not have **gastroenteropancreatic neuroendocrine tumors (GEP-NETs)** cannot participate. These are a type of tumor that affects certain parts of the digestive system and pancreas.
  • Patients who are unable to undergo a **PET scan** cannot participate. A PET scan is a type of imaging test that helps doctors see how the organs and tissues inside your body are working.
  • Patients who cannot receive **radiolabeled somatostatin analogs (SSA)** cannot participate. These are special medicines used in the study to help see the tumors better during the PET scan.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
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Investigated drugs

  • 68Ga-DOTA-peptides

    are used in this trial for imaging purposes. These peptides are labeled with a radioactive substance called Gallium-68. They help in visualizing certain types of tumors, specifically gastroenteropancreatic neuroendocrine tumors, by highlighting them on a PET scan. This allows doctors to see the tumors more clearly and assess their size and location.

  • 177Lu-DOTA-peptides

    are used for therapy in this trial. These peptides are labeled with a radioactive substance called Lutetium-177. They are designed to target and treat gastroenteropancreatic neuroendocrine tumors by delivering radiation directly to the tumor cells. This helps in reducing the size of the tumors and controlling their growth.

What is already known about the treatment

177Lu-DOTA-peptides – This medication is administered through an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. It is a form of peptide receptor radionuclide therapy, which targets specific receptors on tumor cells using a radioactive substance. The main therapeutic indication is for patients with liver metastases from GEP-NETs. At the molecular level, it works by binding to somatostatin receptors on the tumor cells, allowing the radioactive component to deliver targeted radiation to the cancer cells. It is classified as a radiopharmaceutical used in targeted cancer therapy.

Investigated diseases

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Adults – These are a group of rare tumors that originate from neuroendocrine cells in the gastrointestinal tract and pancreas. They can produce hormones that cause various symptoms, depending on the location and type of tumor. GEP-NETs can grow slowly or rapidly, and their progression varies widely among individuals. They may spread to other parts of the body, such as the liver, leading to additional complications. The tumors are often classified based on their grade, which indicates how quickly they are likely to grow and spread. Understanding the behavior of these tumors is crucial for managing their impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514785-39-00Protocol codeCHUBX 2017/47Estimated enrolment23 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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