AuthorisedTherapeutic use (Phase IV)Interventional

Prognostic value of early assessment by ⁶⁸Ga-DOTATATE PET/CT for the treatment of well-differentiated grade 2 gastroenteropancreatic neuroendocrine tumors with ¹⁷⁷Lutetium-oxodotreotide.”

This study is investigating whether a specific type of early scan, called a ⁶⁸Ga-DOTATATE PET/CT, can help predict how well a treatment called Lutetium-177 (SomaKit TOC) will work for people with a particular type of cancer. The cancers are well-differentiated grade 2 gastroenteropancreatic neuroendocrine tumours, which means they are found in the gut or pancreas and are moderately growing. The main goal is to see if early scan results can give doctors a good idea of how long the treatment will keep the cancer from growing or spreading. This helps doctors understand if the treatment is effective and if early signs can guide future care for these patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre De Lutte Contre Le Cancer Eugene Marquis

Enrolment target

Start

18 May 2026

Gastroenteropancreatic neuroendocrine tumors

What is this study about?

This study is called a 'post-marketing' study, which means it's looking closely at a treatment (Lutetium-177, also known as SomaKit TOC) that is already approved for use. The focus is on a specific type of cancer called gastroenteropancreatic neuroendocrine tumours, which are rare growths that can appear in parts of your digestive system, like your stomach, intestines, or pancreas. These tumours are described as 'well-differentiated grade 2,' meaning their cells look somewhat like normal cells, and they are growing at a moderate speed.

The main aim of the research is to understand if a special type of scan, called a ⁶⁸Ga-DOTATATE PET/CT scan, can help predict how well the Lutetium-177 treatment will work. This scan is done early in the treatment process. Doctors want to see if the results from this early scan can tell them how long the treatment will prevent the cancer from growing or spreading. This is known as 'progression-free survival' – essentially, how long you live without your cancer getting worse.

By understanding this better, doctors hope to gain valuable insights into who might benefit most from this treatment and potentially adjust care more effectively based on these early scan results. It helps to ensure that patients are receiving the most effective treatment for their specific condition.

Key takeaways

This study helps understand an existing cancer treatment better.
It's for specific neuroendocrine tumours in the gut or pancreas.
Researchers are checking if an early scan predicts treatment success.
The treatment used (Lutetium-177) is already approved.
Results could help doctors personalise future patient care.

Who may be eligible?

This study is looking for adults who are at least 18 years old or older. Both men and women can take part.

The study is specifically for patients who have been diagnosed with certain types of neuroendocrine tumours. These tumours must be in the gut or pancreas, and doctors will have classified them as 'well-differentiated grade 2.' Your medical team will be able to confirm if your specific cancer fits this description.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you been diagnosed with a neuroendocrine tumour in your gut or pancreas?
Has your doctor confirmed your tumour is 'well-differentiated grade 2'?
Are you receiving or suitable for Lutetium-177 treatment (SomaKit TOC)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the Lutetium-177 treatment as prescribed by your doctor. The study will mainly involve keeping track of your progress through regular check-ups and scans. You will have CT scans every three months after you start the treatment to see how the cancer is responding. There will also be a special ⁶⁸Ga-DOTATATE PET/CT scan taken just before your third treatment injection. The information from these scans will be carefully reviewed by experts.

The study doesn't change the treatment you receive, but it helps doctors to understand the treatment better. You'll continue with your regular medical appointments and follow-up care for the duration needed to assess the treatment's effect on your cancer.

Potential risks and benefits

Taking part in this study doesn't involve receiving new or experimental medicines, as SomaKit TOC is already an approved treatment. The potential benefit is that the study might help doctors understand more about how well this treatment works for specific patients, which could improve future care for others with similar cancers. As with any medical treatment, there are potential side effects from Lutetium-177, and your doctor will discuss these with you. Your health and well-being are the top priority, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What kind of cancer is this study about?

This study focuses on specific types of neuroendocrine tumours found in the gut or pancreas that are considered 'well-differentiated grade 2,' meaning they grow at a moderate pace.

What is the main goal of this study?

The main goal is to see if an early special scan (PET/CT) can predict how long a treatment called Lutetium-177 will prevent the cancer from growing or getting worse.

Will I receive a new medicine if I join?

No, the treatment being studied, Lutetium-177 (SomaKit TOC), is already an approved medicine for this type of cancer. The study is observing its use.

What does 'progression-free survival' mean?

It means the amount of time that passes after starting treatment before the cancer starts to grow or spread again.

Do I have to attend extra appointments for this research?

The study uses information from your planned regular CT scans and a specific PET/CT scan done before your third Lutetium-177 treatment. It doesn't add many extra appointments beyond your usual care.