RecruitingOBSERVATIONAL

The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

This study, called PROGRAM, is looking into the best way to remove a type of brain tumour called glioblastoma, especially when it's in a part of the brain that controls important functions like movement or speech. Doctors want to see if using different brain mapping methods during surgery makes a difference compared to not using them at all. Patients in the study will have surgery in one of three ways: either awake with real-time brain mapping, asleep with brain mapping, or asleep without any special mapping. The aim is to understand which approach helps remove the most tumour while keeping the patient safe and protecting crucial brain functions. This research brings together many hospitals to find better ways to treat this challenging condition.

At a glance

Status

Recruiting

Sponsor

Erasmus Medical Center

Enrolment target

453

Start

01 Jan 2022

Estimated completion

01 Oct 2026

Glioblastoma

What is this study about?

This study is called the PROGRAM study. It's looking at how best to remove a serious type of brain tumour called glioblastoma, especially when it's located in or very near important brain areas that control things like movement, speech, or senses. Doctors want to understand whether using special techniques during surgery to map these crucial brain areas helps patients more than not using them.

The study divides patients into three groups, and each group will have surgery in a slightly different way. One group will have what's called 'awake mapping', where the patient is awake during part of the surgery. This allows surgeons to test brain functions like speaking or moving a hand in real-time as they remove the tumour. Another group will have 'asleep mapping', where special electrical tests are used to monitor brain function while the patient is fully asleep. The third group will have their tumour removed while fully asleep, but without these specific mapping techniques.

By comparing these three approaches, the researchers hope to find out which method is safest and most effective for removing as much of the tumour as possible, while also protecting the patient's brain function. This is an international study, meaning many hospitals in different countries are taking part, which helps gather a lot of information to help future patients with glioblastoma.

Key takeaways

The study compares three ways to remove brain tumours (glioblastoma): awake mapping, asleep mapping, or no mapping.
It aims to find the safest and most effective surgical method to protect important brain functions.
Participation involves having one of these types of surgery, followed by standard medical care.
The study is for adults with glioblastoma near crucial brain areas.
It's a way for doctors to improve care for future patients.

Who may be eligible?

To join this study, you need to be an adult between 18 and 90 years old. Doctors must suspect you have a glioblastoma tumour, based on your MRI scan, which they believe can be safely removed. Your tumour must also be in or very close to important brain areas, like those that control movement, speech, or vision. You also need to be able to understand the study and give your written permission to take part.

There are some reasons why you wouldn't be able to join. For example, if your tumour is in certain parts of the brain like the brain stem or cerebellum. You also can't participate if you have other medical issues that prevent you from having an MRI scan, or if you have multiple tumours that show up brightly on your scans. If you've had another cancer in the last five years (and it wasn't a very early-stage skin cancer or a specific type of non-invasive cancer), you also won't be able to join.

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 between 18 and 90 years old?
Has your doctor suggested your tumour might be glioblastoma, visible on an MRI?
Is your tumour located near important brain areas like those for movement or speech?
Has your doctor said your tumour appears suitable for removal surgery?
Can you provide written consent to join the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have surgery to remove your brain tumour. Depending on which group you are assigned to, your surgery will either involve being awake for a portion of the procedure with brain mapping, being asleep with brain mapping, or being asleep without brain mapping. After your surgery, you will receive your usual medical care and follow-up, just as any patient with your condition would. The study itself doesn't involve extra visits or assessments beyond what your doctors would normally do to monitor your recovery and treatment. There are no special medications involved in the study itself. The total duration of your participation will depend on your standard medical follow-up, as the study primarily observes the outcomes of the different surgical approaches.

Potential risks and benefits

Participating in this study might help doctors understand the best and safest ways to treat glioblastoma in the future. You will receive very careful medical attention during and after your surgery, just as all patients would. However, as with any surgery, there are always potential risks, and there might not be any direct benefit to you personally. The different surgical approaches are well-established, but the study aims to compare their effectiveness more formally. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

University of California, San Francisco
Verified postcode
San Francisco, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
University Hospitals Leuven
Verified postcode
Leuven, Belgium· Not yet recruiting
University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Not yet recruiting
Technical University Munich
Verified postcode
Munich, Germany· Not yet recruiting
Erasmus MC
Verified postcode
Rotterdam, Netherlands· Recruiting
Medical Center Haaglanden
Verified postcode
The Hague, Netherlands· Not yet recruiting
Inselspital Universitätsspital Bern
Verified postcode
Bern, Switzerland· Not yet recruiting

Common questions

What is glioblastoma?

Glioblastoma is a serious type of brain tumour that grows quite quickly.

What does 'brain mapping' mean?

Brain mapping is a way doctors find important brain areas, like those for movement or speech, during surgery to try and protect them.

Will I be awake during the surgery?

Some patients in the study might be awake during a part of their surgery, if their doctor decides that's the best approach for them and their tumour. Other patients will be fully asleep for their surgery.

How long does the study last for me?

The study observes your recovery and follow-up as part of your standard medical care, so there's no set end date for your participation beyond your usual treatment journey.

Can I choose which surgery I have?

The different surgical approaches are part of the study design. Your doctor will discuss the best option for your specific situation and tumour.

How to find out more

Jasper Gerritsen, MD

j.gerritsen@erasmusmc.nl +31629119553 Official trial record

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