Study on [18F]-Fludarabine and Gadoteric Acid for Imaging in Patients with Newly Diagnosed Primary CNS Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called primary central nervous system lymphoma, which affects the brain and spinal cord. The study will use a special imaging technique called PET-MRI to look at how a new drug, [18F]fludarabine, is taken up by the cancer. This drug is given as a solution through a vein, which is known as an infusion. The study will also use another substance called gadoteric acid, which is a solution injected into the body to help improve the quality of the MRI images.

The purpose of the study is to understand how [18F]fludarabine spreads in the brain and how much of it is absorbed by the cancer before any surgery, chemotherapy, or radiotherapy is done. Participants will undergo imaging tests to see how the drug interacts with the cancer and healthy brain tissue. The study will help researchers learn more about the behavior of this type of lymphoma and how it can be better diagnosed and treated in the future.

During the study, participants will receive the [18F]fludarabine infusion and undergo PET-MRI scans. These scans will help measure the amount of the drug in the tumor compared to healthy tissue. The study will also look at other factors like the size of the tumor and how it affects the brain. This research aims to provide valuable insights into the treatment and management of primary central nervous system lymphoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (18 years or older), diagnosis of high-grade central nervous system (CNS) lymphoma, and other health criteria.

The patient must not have undergone any chemotherapy, radiotherapy, or surgery for CNS lymphoma prior to the trial.

2 consent process

The patient or a legal representative must sign an informed consent form. This document explains the study’s purpose, procedures, and potential risks.

3 imaging preparation

The patient is prepared for imaging procedures. This involves ensuring that the patient meets all necessary health criteria, such as adequate kidney function (creatinine clearance of at least 30 mL/min).

4 administration of gadoteric acid

Gadoteric acid, a contrast agent, is administered as a solution for infusion. This helps enhance the quality of MRI images.

5 administration of [18F]fludarabine

[18F]fludarabine is administered parenterally, meaning it is given by injection. This radioactive tracer is used for PET imaging to assess the distribution and uptake in the brain.

6 PET-MRI imaging

The patient undergoes PET-MRI imaging. This combined imaging technique provides detailed pictures of the brain and helps measure the uptake of [18F]fludarabine in tumor lesions compared to healthy tissue.

7 data analysis

The images are analyzed to determine the standardized uptake value (SUV) of [18F]fludarabine in tumor lesions. This helps in understanding the tumor’s characteristics and behavior.

8 follow-up

The patient may be required to attend follow-up visits for additional assessments and to monitor any changes in health status.

Who Can Join the Study?

Patients must be 18 years or older.
Must have a newly diagnosed high-grade CNS lymphoma, confirmed by tests that look at cells or tissues.
Should not have received any chemotherapy or radiotherapy for CNS lymphoma.
Must have a contrast-enhanced intracranial mass that is at least 1 cm in size.
Must have a Karnofsky index of 40 or higher. This is a score that measures a patient’s ability to perform everyday activities.
Should not have systemic lymphoma as shown by a specific type of scan called [18F]-FDG PET/CT.
Must have a creatinine clearance of 30 mL/min or higher. This is a test that checks how well the kidneys are working.
Must be affiliated with social security, but not under a specific program called AME.
Must sign an informed consent form, or have it signed by a legal representative or close relative if unable to do so.

Who Cannot Join the Study?

Patients who have already had surgery, radiotherapy, or chemotherapy for their primary central nervous system lymphoma cannot participate.
Individuals who do not have a newly diagnosed primary central nervous system lymphoma are excluded.
Participants must be within the specified age range for the study.
Both male and female participants are eligible, but certain vulnerable populations may be excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France
Gdrcih Hphdlhxtlix Ncdu Enfquou	Orsay	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.12.2023

Trial locations

Investigated drugs:

[18F]-Fludarabine is a special imaging agent used in this study to help doctors see how it spreads in the brain. It is used with PET-MR imaging to look at primary central nervous system lymphomas, which are a type of brain cancer. This helps doctors understand more about the cancer before any surgery, chemotherapy, or radiotherapy is done.

Primary Central Nervous System Lymphoma – This is a rare type of non-Hodgkin lymphoma that occurs in the brain, spinal cord, or eyes. It originates from lymphocytes, which are a type of white blood cell, and forms tumors in the central nervous system. The disease typically presents with neurological symptoms such as headaches, seizures, or changes in personality, depending on the tumor’s location. As it progresses, it can affect cognitive functions and lead to further neurological impairments. The disease is distinct because it does not usually spread outside the central nervous system. It is often diagnosed through imaging studies and biopsy to confirm the presence of lymphoma cells.

Trial ID:

2024-512758-62-00

Protocol code:

P160407

NCT ID:

NCT05390814

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on [18F]-Fludarabine and Gadoteric Acid for Imaging in Patients with Newly Diagnosed Primary CNS Lymphoma

What is this study about?

Who Can Join the Study?

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