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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Cvjrre Encran Mdqjmfd	Rennes	France
Hldfzre Czrpdo Baxudiz Cvj di Bulti	Brest	France
Ckr Nzrcjb	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	30.06.2026

Trial locations

Investigated drugs:

Edotreotide

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.

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 ID:

2025-524942-87-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?