Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT05671016

Brain Imaging to Predict Toxicity in Elderly Patients After Radiotherapy

Conditions: Glioblastoma Multiforme, Adult, Radiation Toxicity, Quality of Life

Sex: All
Ages: 65 Years – N/A
Enrollment: 125
Sponsor: Brighton and Sussex University Hospitals NHS Trust

Location: United Kingdom

Summary

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.

Eligibility Criteria

Inclusion Criteria:• Patients aged > 65 years with a new diagnosis of GBM. Diagnosis made via histological confirmation following biopsy or debulking surgery or radiologically during a Multidisciplinary meeting (MDM) confirmed by a consultant neuro radiologist. This lower age limit is due to previous clinical trials which have established gold standard treatment regimes for patients under the age of 65. Patients aged 65 or over have less clinical trial data available to them and treatment decisions are more nuanced with a greater emphasis on quality of life given the poorer prognosis of older patients.Patients undergoing radiotherapy treatment to the brain for treatment of their GBMPatients able to undergo an MRI scanPatients undergoing treatment at one of the study centresPatient have capacity to participate in the studyPatients with physical impairments that prevent them filling in their questionnaires involved in the study may still participate if they are able to communicate their answers though a third partyExclusion Criteria:• Patients not fit for radiotherapy treatment or having single agent chemotherapy with no radiotherapyPatients lacking capacityPatients who do not have sufficient grasp of the English language to be able to complete the questionnairesPatients unable to communicate their responses to the questionnairesPatients who are concurrently enrolled in a Clinical Trial of an Investigational Medicinal Product (CTIMP)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05671016). StuddyBuddy aggregates publicly available trial information.