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68Ga-DOTATATE PET/CT Prognostic Assessment in Patients with Well-Differentiated Grade 2 Gastroenteropancreatic Neuroendocrine Tumors Treated with 177Lu-oxodotreotide and Edotreotide

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 studying gastroenteropancreatic neuroendocrine tumors, which are rare tumors that start in the stomach, intestines, pancreas, or nearby areas. The treatment used in the study is ¹⁷⁷Lu-oxodotreotide, a radioactive medicine given into a vein. The purpose of the study is to see whether an early scan before the third treatment can help predict how long the cancer stays under control.

In this study, a special imaging test called ⁶⁸Ga-DOTATATE PET/CT is done before the third injection of ¹⁷⁷Lu-oxodotreotide. A PET/CT scan combines two types of scans to show where the tumor is in the body and how active it is. Treatment is given first, and then scans are repeated during follow-up to watch for any signs that the tumor is growing again. The study looks at how the scan results relate to the course of the disease over time.

The medicine being studied may also be listed as edotreotide in some products, and the imaging agent used for the scan is ⁶⁸Ga-edotreotide. The trial focuses on patients with well-differentiated grade 2 disease, which means the tumor cells still look somewhat like normal cells under a microscope, but the cancer can still grow and spread.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of treatment

    You begin treatment with ¹⁷⁷lu-oxodotreotide. The first injection marks the start of the study treatment period.

    The study uses edotreotide in the form of ⁶⁸ga-dotatate pet/ct imaging. pet/ct means a scan that combines two types of pictures: one that shows how tissues work and one that shows detailed body images.

  2. Step 2

    Treatment injections

    You receive ¹⁷⁷lu-oxodotreotide by intravenous injection, which means it is given into a vein.

    The dose is 200 mbq/kg for each administration. mbq means megabecquerel, a unit used to measure radioactivity.

    The treatment is given as part of the study schedule, and the scan assessment is planned just before the 3rd injection.

  3. Step 3

    Scan before the third injection

    Just before the 3rd injection of ¹⁷⁷lu-oxodotreotide, you have a ⁶⁸ga-dotatate pet/ct scan.

    The scan images are reviewed separately to assess the disease.

  4. Step 4

    Follow-up tumor checks

    After treatment starts, your tumors are checked every 3 months using ct scans. ct means computed tomography, a scan that creates detailed pictures of the inside of the body.

    These scans are used to look for the first documented tumor progression, which means the first clear sign that the tumor has grown or worsened according to the study rules.

  5. Step 5

    Study outcome period

    The study measures the time from the first injection of ¹⁷⁷lu-oxodotreotide until the first documented tumor progression during follow-up.

    This time period is called progression-free survival, which means the length of time during which the disease does not get worse.

Who can join the trial?

7 criteria

  • Be at least 18 years old when signing the written informed consent form, which means the patient agrees to take part in the study in writing.
  • Have a well-differentiated grade 2 metastatic gastroenteropancreatic neuroendocrine tumor. This means the tumor started in the digestive system or pancreas, has spread to other parts of the body, and the cells still look somewhat like normal cells under a microscope.
  • Have a tumor with a Ki-67 value of 3% to 20%. Ki-67 is a test that shows how fast the tumor cells are growing.
  • Be planned to receive 177Lu-oxodotreotide, a treatment using a radioactive medicine.
  • Have had a 68Ga-edotreotide PET/CT scan within 2 months before the first 177Lu-oxodotreotide injection. A PET/CT scan is an imaging test that combines two types of scans to show where the tumor is in the body.
  • Provide written informed consent before joining the study.
  • Be covered by or eligible for a social security system, meaning the patient has official health coverage or benefits.

Who cannot join the trial?

3 criteria

  • Being pregnant or breastfeeding.
  • Being a protected person under French public health law, which includes people who cannot legally give consent or need special legal protection.
  • Having had a hypersensitivity reaction or anaphylactic reaction after receiving the radiopharmaceutical used for the first PET scan. A hypersensitivity reaction means an allergic-type reaction. Anaphylactic reaction means a severe, sudden allergic reaction that can be life-threatening.
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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

  • CHU Nantes

    Verified

    FranceNantes, France

Trial locations

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Investigated drugs

  • SomaKit TOC

    is a radiopharmaceutical kit used to prepare a tracer for a PET scan. In this trial, it is used to help doctors look at neuroendocrine tumors in the body and measure how the tumors are behaving before treatment continues. The scan helps assess whether the tumor is likely to respond well to the planned therapy and can give information about the patient’s prognosis.

  • ¹⁷⁷Lutetium-oxodotreotide

    is the main treatment being studied. It is a targeted radiation therapy that travels through the bloodstream and binds to certain receptors found on neuroendocrine tumor cells. Once attached, it delivers radiation directly to the tumor cells to help slow or stop their growth while trying to limit damage to healthy tissue.

What is already known about the treatment

Edotreotide - Edotreotide is used as a solution for injection in a radiopharmaceutical kit and is given by intravenous injection after it is prepared for use. It is an active substance still used in modern nuclear medicine and is well described in medical literature, especially for imaging certain tumors. It is mainly used to help find and assess neuroendocrine tumors, such as gastroenteropancreatic neuroendocrine tumors, because these tumors often have special receptors on their surface. Edotreotide is a small peptide that binds to somatostatin receptors, especially the subtype found on these tumor cells, and this allows the radioactive signal to collect in the tumor so it can be seen on scans. It belongs to the pharmacological group of radiopharmaceuticals used for tumor imaging.

Investigated diseases

Gastroenteropancreatic neuroendocrine tumors - These are rare tumors that begin in hormone-producing cells of the digestive system or pancreas. They often grow slowly, but some can become more aggressive over time. They may spread to nearby tissues or to other parts of the body as they progress.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524942-87-00Estimated enrolment40 patientsSponsorCentre De Lutte Contre Le Cancer Eugene Marquis

sourced from the EU Clinical Trials Register and site verification

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