Brain Imaging Biomarkers in Patients With Brain Metastasis

Official Title

Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiation Therapy

Summary:

A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-centre phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.

Trial Description

Primary Outcome:

• Response Assessment in Neuro-Oncology (RANO) to validate biomarkers
• Response Evaluation Criteria in Solid Tumours (RECIST) criteria to validate biomarkers
• Progression Free Survival (PFS) to validate biomarkers

Secondary Outcome:

• Objective (Radiological) Progression
• Objective (Radiological) Response
• Time to Intracranial Local Progression
• Time to Intracranial Distant Progression
• Brain Progression Free Survival
• Unexpected and/or Serious Toxicities (AEs)

Advances in medical imaging can provide useful information to guide and look at the response to treatment. Previous studies suggest early changes in the tumour after radiation treatment may be detectable using special MRI (Magnetic Resonance Imaging), and CT (Computed Tomography) scans. A biomarker is a measureable indicator of the severity or presence of some disease state. Previous studies suggest that the change in several imaging biomarkers can predict who will respond to radiation treatment. In this study, patients will undergo CT and MRI scans prior to and after radiation treatment to measure these biomarkers. The purpose of this study is to validate the predictive abilities of biomarkers in terms of determining how patients will respond to radiation treatment. This is a single-centre phase II study, which will be conducted at the Princess Margaret Cancer Centre. The study will be enrolling up to a total of 90 patients who will be receiving radiation treatment for brain metastases. Patients will be asked to participate within this study for 2 years.

View this trial on ClinicalTrials.gov