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

Fast replyRegistered 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 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.

The research process

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

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

9 criteria

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.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Assistance Publique Hopitaux De Paris
Verified
Paris, France
Hospices Civils De Lyon
Responsive
Lyon, France

Trial locations

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Investigated drugs

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.

Fluorodopa (18F)

What is already known about the treatment

18F-FDOPA – This medication is administered as an injection and is used in a PET scan, a type of imaging test. It is currently being studied in clinical trials to improve the diagnosis of low-grade gliomas, a type of brain tumor. The main use of 18F-FDOPA is to help doctors see how aggressive a brain tumor might be, which can guide treatment decisions. At the molecular level, 18F-FDOPA works by mimicking natural substances in the brain, allowing it to highlight areas of abnormal cell activity during imaging. It is classified as a radiopharmaceutical, which means it is a radioactive compound used for medical imaging.

Investigated diseases

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.