RecruitingPHASE2INTERVENTIONAL

Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma

This study is investigating a new, more advanced method for planning proton beam radiation therapy for people with low-grade glioma. Low-grade glioma is a type of brain tumour that grows slowly, often affecting younger adults. The main goal is to see if using a special computer model to guide the treatment plan can help reduce certain side effects that can appear months after treatment. These side effects, called late contrast-enhancing brain lesions (CEBLs), can sometimes cause problems. Researchers want to make the treatment as effective as possible while also protecting important brain functions and improving long-term quality of life. This is a Phase 2 study, meaning it's still in the earlier stages of testing this new approach.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital Heidelberg

Enrolment target

120

Start

11 Nov 2023

Estimated completion

11 Nov 2028

Low Grade Glioma

What is this study about?

This study is about finding a better way to treat a type of brain tumour called low-grade glioma. These tumours usually grow slowly and often affect younger adults, meaning people live with them for a long time. Because of this, it's really important to make sure the treatment has as few long-term side effects as possible.

Radiation therapy, which uses powerful beams to target and destroy cancer cells, is an important treatment for low-grade glioma. Proton beam therapy is a type of radiation that is designed to be very precise, delivering a high dose to the tumour while trying to spare healthy surrounding tissue. While proton therapy shows a lot of promise, sometimes after treatment, new spots called 'late contrast-enhancing brain lesions' (CEBLs) can show up on follow-up scans. These aren't new tumours, but they are an unwanted side effect.

Researchers have noticed that these CEBLs tend to appear in specific parts of the brain. This study wants to see if using a special computer model can help doctors plan proton beam therapy in a way that avoids these problematic areas. By using this model, the hope is to create a more tailored and safer treatment plan for each person, aiming to reduce the risk of these late side effects and improve the overall quality of life for people living with low-grade glioma.

Key takeaways

This study is testing a new way to plan radiation for low-grade glioma.
It aims to reduce specific long-term side effects of treatment.
The new method uses computer models to create more precise treatment plans.
Participation could mean getting a tailored treatment plan.
It's open to adults aged 18 and over with low-grade glioma needing radiotherapy.

Who may be eligible?

To be considered for this study, you must be 18 years old or older and have a confirmed diagnosis of low-grade glioma. Your doctors must also have determined that you need radiation therapy as part of your treatment plan.

It's important that you understand what's involved in taking part in the study and are willing to give your written permission to participate.

You would not be able to join this study if you have had radiation therapy to your brain before. Also, if you have certain medical conditions like neurofibromatosis, or if you can't have a special type of MRI scan (contrast-enhanced MRI), you unfortunately wouldn't be eligible. Lastly, if you're already taking part in another study that has similar goals, you wouldn't be able to join this one.

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 18 years old or older?
Do you have a diagnosis of low-grade glioma?
Has your doctor said you need radiation therapy?
Have you *not* had radiation therapy to your brain before?
Can you have an MRI scan with contrast dye?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the standard proton beam radiation treatment plan or a plan that has been specially optimised using a computer model. The study will involve regular check-ups and MRI scans to monitor your progress and look for any side effects. The exact number of visits and scans would be explained in detail by the study team. They will also tell you how long you would be followed up after your treatment finishes. All details about your specific treatment and follow-up schedule would be fully discussed with you before you agree to participate.

Potential risks and benefits

Potential benefits of taking part could include receiving a treatment plan designed to reduce certain long-term side effects, which might lead to a better quality of life. You would also be contributing to important research that could help others with low-grade glioma in the future. As with any medical treatment or study, there are potential risks, and these will be fully explained to you by the study team. They might include known side effects of proton beam therapy or side effects that are specific to the study's approach. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Department of Radiotherapy, University of Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is low-grade glioma?

Low-grade glioma is a type of brain tumour that typically grows slowly and is sometimes found in younger adults.

What is proton beam therapy?

It's a type of radiation treatment that uses tiny particles called protons to target tumours very precisely, aiming to protect healthy tissue nearby.

What are 'late contrast-enhancing brain lesions' (CEBLs)?

These are unwanted spots that can sometimes show up on brain scans months after radiation treatment. This study hopes to reduce them.

What does 'model-guided optimization' mean?

It means using special computer programmes and models to help doctors design the most effective and safest radiation treatment plan for you.

Will I definitely get the new treatment plan?

Participants in this study will either receive the standard treatment plan or the new model-guided optimized plan, as part of the research.

How to find out more

Semi Harrabi, MD

semi.harrabi@med.uni-heidelberg.de +496221 56 Official trial record

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