Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

[18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study

This research is investigating a new imaging technique for people recently diagnosed with a type of brain cancer called primary central nervous system (CNS) lymphoma. The study uses a special substance called [18F]-Fludarabine, which is combined with a PET-MRI scan. Doctors want to see if this new scan can accurately show the cancer by measuring how much of the special substance the tumour takes up, compared to healthy parts of the brain. The goal is to find out if this advanced imaging method could help us better understand and treat this type of cancer in the future, without needing surgery, radiation, or chemotherapy beforehand.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

08 Nov 2024

Patients with newly diagnosed primary central nervous system lymphoma naïve to surgery radiotherapy or chemotherapy

What is this study about?

This study is a research project focusing on a specific type of cancer called primary central nervous system (CNS) lymphoma. This is a cancer that starts in the brain or spinal cord. When someone is first diagnosed with this condition, and hasn't yet started any treatments like surgery, radiation, or chemotherapy, doctors want to see if a new scanning method can help them understand the cancer better.

The new method combines two types of scans: a PET scan and an MRI scan. For the PET scan, a small, safe amount of a special substance called [18F]-Fludarabine is used. This substance is designed to be taken up by cancer cells. The study will measure how much of this substance the tumour absorbs compared to the healthy surrounding brain tissue. The MRI part of the scan gives very detailed pictures of the brain structure.

The main aim is to find out if these combined scans can clearly show the cancer and measure its activity. Researchers will compare these findings with other measures, like how the brain uses energy and blood flow in the tumour, to get a full picture. The hope is that this new scanning technique could provide valuable information to doctors, potentially leading to better ways to diagnose and monitor this type of brain lymphoma in the future.

Key takeaways

This study is for people newly diagnosed with brain lymphoma.
It uses an advanced PET-MRI scan with a special tracer.
The aim is to improve how we identify and understand this cancer.
Participation involves a single scanning session.
It's not a treatment study, but aims to help future patients.

Who may be eligible?

This study is looking for volunteers who have just been diagnosed with primary central nervous system lymphoma.

To be considered, you must not have had any treatment for your cancer yet, including surgery, radiotherapy (radiation therapy), or chemotherapy. This is important because the researchers want to see how the scan works on cancer that hasn't been changed by treatment.

You need to be 18 years old or older to take part. This study is open to both men and women.

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.

Have I just been diagnosed with brain or spinal cord lymphoma?
Have I not had any treatment for my cancer yet (like surgery, radiation, or chemotherapy)?
Am I 18 years old or older?
Am I willing to have a special scan with an injected substance?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special scan called a PET-MRI. Before the scan, you will be given a small, safe amount of a special substance called [18F]-Fludarabine, usually through an injection. You will also receive another common contrast agent called GADOTERIC ACID, which helps improve the MRI images.

The PET-MRI scan will measure how much of the [18F]-Fludarabine your tumour takes up, and how it's distributed in your brain. The researchers will also look at other details from the MRI, such as tumour size, blood flow to the tumour, and its chemical makeup. This is typically a single visit for the scanning process. The total duration of your participation would be for this scan and any necessary follow-up for the study.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained could help other patients with similar conditions in the future by improving diagnosis and understanding of this cancer. Potential risks involve those typically associated with PET and MRI scans, such as exposure to a small amount of radiation from the PET tracer, and potential allergic reactions to the injected substances, though these are rare. You have the right to withdraw from the study at any time, without giving a reason, and it will not affect your usual 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 is primary central nervous system (CNS) lymphoma?

It's a type of cancer that begins in the brain or spinal cord.

What is the purpose of the [18F]-Fludarabine substance?

It's a special substance given before the scan that helps highlight the cancer cells so doctors can see them better.

What is a PET-MRI scan?

It's a combination of two powerful scans (PET and MRI) that work together to give doctors detailed pictures and information about the cancer.

Will I receive treatment as part of this study?

No, this study is about a new way to scan the cancer, not a new treatment. You will still receive your regular care after the scan.

Is the radiation from the scan safe?

The amount of radiation used for the PET scan is very small and carefully monitored, similar to other common medical scans.