RecruitingPHASE2INTERVENTIONAL

Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study

This study is for people with glioblastoma, a type of brain cancer, that has come back. Even with standard treatments, recurrence is common. This trial explores a new approach using special imaging scans, called FDOPA-PET, to guide radiation therapy more accurately. The goal is to deliver a stronger dose directly to the tumor while protecting healthy brain tissue, by combining advanced radiation techniques. Researchers hope this more targeted method will be more effective in shrinking recurrent tumors, which are often hard to treat. This is a Phase II study, meaning it's testing if the treatment works and is safe in a group of patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Paul Strauss

Enrolment target

Start

01 Mar 2026

Estimated completion

01 Sep 2028

Glioblastoma

What is this study about?

Glioblastoma is the most common and aggressive type of brain tumour in adults. Despite surgery, chemotherapy, and radiation therapy, it often comes back, usually within about six months. When it does, treatment options become more limited, and current approaches aren't always successful. Doctors are constantly looking for better ways to manage this challenging disease.

This study explores a new way to give radiation therapy when glioblastoma returns. Normally, doctors use MRI scans to see the tumour. However, special PET scans, which use a tracer called FDOPA, can sometimes show the active parts of the tumour more clearly, especially differentiating between a growing tumour and other changes in the brain after previous treatments. The idea is that if doctors can see the active parts of the tumour more precisely with these PET scans, they can aim the radiation more accurately.

The specific technique being tested is called "Simultaneous Integrated Boost" (SIB) with Intensity-Modulated Radiation Therapy (IMRT). This allows a higher dose of radiation to be delivered to the parts of the tumour that are most active (as shown by the FDOPA-PET scan), while reducing the dose to surrounding healthy brain tissue. The aim is to make the radiation therapy more effective against the returning tumour without causing too many side effects. This trial hopes to find out if this focused approach truly improves treatment for people whose glioblastoma has come back.

Key takeaways

This study uses advanced FDOPA-PET scans to guide targeted radiation for recurrent glioblastoma.
It aims to deliver a stronger, more precise radiation dose to the tumour while protecting healthy brain tissue.
This is a Phase II trial, meaning it's assessing if the treatment works and is safe.
Participation involves special scans and a specific type of radiation therapy, with regular follow-up.
The goal is to improve treatment options for glioblastoma that has come back.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 years or older who have been diagnosed with a specific type of brain tumour called glioblastoma (WHO grade IV), and whose tumour has unfortunately returned. You would need to have had previous radiation treatment in or near the area where the tumour has reappeared.

Your overall health and daily activity levels, often called 'performance status,' should be good (rated 0, 1, or 2), and your neurological condition stable enough for you to participate. The returning tumour should be a certain size and number (1 to 3 spots, each smaller than 3.5cm and under 35mL in volume), and a safe distance (more than 1cm) from important structures like your optic nerves or brainstem. Also, you must not have a condition called "glioblastomatosis", where the tumour is widespread.

There are also some reasons you might not be able to join, such as if you are pregnant or breastfeeding, have a condition that prevents you from having MRI or PET scans, or if you can't understand the study information in French (the original language of protocol was in French, implying study might be in a French-speaking region). It's also important to be able to attend appointments and give your full consent to participate.

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.

Are you an adult aged 18 or older?
Have you been diagnosed with glioblastoma (WHO grade IV) that has returned?
Have you previously had radiation treatment in or near the area where the tumour is now?
Is your overall health generally good, allowing you to manage daily activities?
Is the returning tumour(s) within specific size limits and not too close to vital brain structures?
Are you able to undergo MRI and PET scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have special FDOPA-PET scans in addition to your regular MRI scans to help plan your treatment. The study involves a type of advanced radiation therapy, which will be given with a "simultaneous integrated boost" based on these detailed scans. This means you'll receive carefully targeted radiation over several sessions.

Throughout the study, you would have regular check-ups, which include physical examinations, neurological assessments, and repeat MRI scans to monitor how you're responding to the treatment and to keep an eye on any side effects. You might also have further PET scans. The exact number of visits and tests will be explained in detail by the study team, but they are all designed to keep you safe and track the treatment's effectiveness. The total duration of your involvement, including follow-up, would depend on your individual response and the study's protocol, but cancer studies typically involve long-term monitoring.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a highly targeted radiation treatment that aims to be more effective against your recurrent glioblastoma than standard approaches, using advanced imaging to guide the therapy. However, like all medical treatments, there are potential risks, including side effects from the radiation therapy, such as fatigue, skin changes, or temporary worsening of neurological symptoms, though the treatment is designed to minimise harm to healthy tissue. It's important to remember that this is a research study, and there's no guarantee of personal benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

CHRU de Nancy
Verified postcode
Nancy, France· Not yet recruiting
Centre Paul Strauss
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is FDOPA-PET and why is it used?

FDOPA-PET is a special type of scan that helps doctors see the most active parts of a brain tumour, which can be useful when planning targeted radiation treatment, especially if the tumour has returned.

What is 'recurrent glioblastoma'?

This means that the glioblastoma, a type of brain tumour, has unfortunately grown back after previous treatments.

What is a 'Simultaneous Integrated Boost' (SIB)?

SIB is an advanced way of giving radiation therapy where a higher dose is delivered directly to the most aggressive part of the tumour at the same time as a standard dose to the wider tumour area, all during the same treatment session.

Will this treatment cure my glioblastoma?

This is a research study to see if a new treatment approach is more effective. While it aims to improve outcomes for recurrent glioblastoma, there's no guarantee of a cure. The goal is to better control the disease.

What is a Phase II study?

A Phase II study is a stage of clinical research that looks at whether a new treatment works and is safe in a larger group of patients than in earlier studies. It helps researchers decide if further, larger studies are needed.

How to find out more

Anne ANTHONY

promotion-rc@institut-strauss.fr (0)388252413 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.