NCT05671016: BRITER

Brain Imaging to Predict Toxicity in Elderly Patients After Radiotherapy

Completed Last updated 4 January 2023

What this trial tests

trial testing MRI scans and questionnaires in Glioblastoma Multiforme, Adult in 125 participants. Completed in 31 December 2021.

Timeline

1 August 2018

Primary endpoint
1 September 2021

31 December 2021

Quick facts

Lead sponsor	Brighton and Sussex University Hospitals NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	125
Start date	1 August 2018
Primary completion	1 September 2021
Estimated completion	31 December 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• MRI scans and questionnaires

Conditions studied

• Glioblastoma Multiforme, Adult — all drugs for Glioblastoma Multiforme, Adult →
• Radiation Toxicity — all drugs for Radiation Toxicity →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Brighton and Sussex University Hospitals NHS Trust

Who can join

65 and older, any sex, with Glioblastoma Multiforme, Adult or Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators' aim with the BRITER study is to produce a way of predicting who might be more or less likely to suffer side effects from radiotherapy prior to starting treatment for a glioblastoma (GBM), a type of brain tumour.

GBM is the commonest primary malignant brain tumour. Treatment options include chemotherapy, radiotherapy or best supportive care. The focus should be on maintaining a good quality of life for as long as possible.

Radiotherapy to the brain is an effective treatment, however it can produce side effects. The degree of side effects different patients experience can vary widely. It has been thought that if the patient's underlying normal brain is fragile due to an underlying mild dementia or problems associated with high blood pressure or cholesterol then this might make them more vulnerable to radiotherapy.

MRI scans can be used to assess whether there are changes in the normal brain. The BRITER study aims to use MRI scans to see whether the investigators can predict those patients who might be more at risk of side effects from radiotherapy. The trial is aimed at patients aged \> 65 who have been newly diagnosed with a GBM and are going to receive radiotherapy. Patients who agree to take part in the trial will have had an MRI scan as part of their normal diagnosis. Participants will undertake some questionnaires before starting their radiotherapy which will aim to assess their quality of life and their mental processes of perception, memory, judgment, and reasoning (called cognitive function). Participants may also need an extra MRI scan.

Participants will repeat these questionnaires 4 and 8 weeks after treatment when they come for their follow up appointments. The investigators will compare them to measurements made on the pre-treatment MRI scan.

Participation in the study does not change the treatment the patient receives.

The investigators hope that the BRITER study will enable them to predict the degree of side effects a patient is likely to experience before embarking on radiotherapy treatment. This will enable more informative, individualised discussions surrounding the best treatment path for older patients with a GBM.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.