Study on Fluorodopa (18F) for Diagnosing Low-Grade Glioma in Patients Without MRI Contrast Enhancement

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of brain tumor known as Low Grade Glioma. The study is exploring the use of a special imaging technique involving a substance called 18F-FDOPA, which is a form of the drug Dopacis. This drug is given as an injection and is used to help doctors see the tumor more clearly on a scan called a PET scan. The purpose of the study is to see how well this imaging technique can help identify more aggressive forms of these tumors, which might not show up on a regular MRI scan.

Participants in the study will receive an injection of Dopacis and then undergo a PET scan. This scan will help doctors understand the characteristics of the tumor better. The study will look at how the tumor absorbs the 18F-FDOPA over time, which can provide important information about the nature of the tumor. This information will be compared to the results of a biopsy or surgery that participants will have within six months of the scan.

The study aims to improve the care of patients with Low Grade Glioma by providing more detailed information about their tumors. This could help doctors make better decisions about treatment options. The trial will continue until 2026, and it is hoped that the findings will lead to better diagnostic tools for these types of brain tumors.

1 initial visit

Upon joining the study, you will attend an initial visit where the research team will review your medical history and confirm your eligibility. This includes verifying that you are between 18 and 75 years old, have a specific type of brain tumor called a low-grade glioma, and meet other criteria such as having had an MRI scan recently.

You will be asked to sign an informed consent form, which confirms that you understand the study and agree to participate.

2 preparation for PET scan

Before the PET scan, you will receive detailed instructions on how to prepare. This may include fasting for a certain period and avoiding certain medications or activities.

The research team will provide you with all necessary information to ensure you are ready for the scan.

3 PET scan procedure

You will undergo a PET scan using a special substance called 18F-FDOPA. This is a solution that will be injected into your vein. The injection is called intravenous administration.

The scan will help the research team assess the characteristics of your brain tumor. The procedure is non-invasive and will take place in a medical facility.

4 follow-up and monitoring

After the PET scan, you will have follow-up visits with the research team. These visits are to monitor your health and gather additional information about your condition.

The team will discuss any findings from the PET scan and may recommend further tests or procedures, such as a biopsy or surgery, within six months of the scan.

5 end of participation

Your participation in the study will conclude after the follow-up period. The research team will provide you with a summary of the findings related to your health.

You will have the opportunity to ask any questions and receive guidance on the next steps for your medical care.

Who Can Join the Study?

Age between 18 and 75 years old
WHO general condition ≤2: This means your overall health is good enough to carry out all normal activities without assistance.
Identification of a single brain tumor at the initial diagnosis with no contrast in the MRI and suspected to be a Low Grade Glioma (LGG), with biopsy or surgery planned within 6 months of the PET scan/CT
MRI performed a maximum of 3 weeks before joining the study, including the usual brain scan sequences (T1, T1 with contrast agent, and T2 FLAIR)
Subject must be affiliated with or a beneficiary of a social security plan
Subject must have received complete information about the study and signed the informed consent form

Who Cannot Join the Study?

Patients with a history of other types of brain tumors.
Patients who have had previous treatment for their brain tumor, such as surgery, radiation, or chemotherapy.
Patients with severe medical conditions that could interfere with the study, such as uncontrolled diabetes or heart disease.
Patients who are pregnant or breastfeeding.
Patients who are unable to undergo a PET scan, which is a type of imaging test that helps doctors see how tissues and organs are functioning.
Patients with allergies to the substances used in the PET scan.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of substance abuse or mental health conditions that could affect their ability to participate in the study.
Patients who do not have the ability to understand and sign the consent form, which is a document that explains the details of the study and confirms their willingness to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Regional Universitaire De Nancy	Nancy	France
Assistance Publique Hopitaux De Paris	Paris	France
Hospices Civils De Lyon	Lyon	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Centre Hospital Region Metz Thionville	Metz	France
Adzegbnhee Prwrqrrw Hvuqcmby Dc Mtsbnkekm	Marseille	France
Chqazs Hdxdwtebocl Rmxrifrj Usgrrjptypmcg Dk Trofv	Tours	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2023

Trial locations

Investigated drugs:

Fluorodopa (18F)

18F-FDOPA is a special type of imaging agent used in a PET scan, which is a kind of medical imaging test. This agent helps doctors see certain areas of the brain more clearly. In this trial, it is used to help identify and understand brain tumors that do not show up well on regular MRI scans. By using this imaging agent, doctors hope to better determine the nature of these tumors, especially to find out if they are aggressive or have certain genetic features that might affect treatment decisions.

Investigated diseases:

Glioma

Low Grade Glioma – Low Grade Glioma is a type of brain tumor that originates from glial cells, which support and protect nerve cells in the brain. These tumors are classified as grade I or II, indicating they are slow-growing and less aggressive compared to higher-grade gliomas. They often occur in younger individuals and can affect various parts of the brain, leading to symptoms such as seizures, headaches, or neurological deficits depending on their location. Over time, Low Grade Gliomas may remain stable or progress to higher-grade tumors, which are more aggressive. The progression can involve changes in the tumor’s cellular structure and genetic makeup, potentially leading to increased growth and spread. Monitoring and regular assessments are crucial to understanding the behavior of these tumors.

Trial ID:

2022-501688-42-00

Protocol code:

2021PI203

NCT ID:

NCT05512403

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Fluorodopa (18F) for Diagnosing Low-Grade Glioma in Patients Without MRI Contrast Enhancement

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?