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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nimes	Nimes	France
Ikiwpwuc Rilaisft Ds Cfptzo Dr Msoggmxzayx	Montpellier	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2021

Trial locations

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.

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 ID:

2024-514785-39-00

Protocol code:

CHUBX 2017/47

NCT ID:

NCT04837885

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?