Brain Imaging Biomarkers in Patients With Brain Metastasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2027-06-30

Brief Summary

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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-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.

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Detailed Description

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Advances in medical imaging can provide useful information to guide and look at the response to treatment. Previous studies suggest early changes in the tumor 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-center phase II study, which will be conducted at the Princess Margaret Cancer Center. 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.

Conditions

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Brain Metastases, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will undergo CT and MRIs before and after radiation therapy.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CT and MRI Scans

Each patient will undergo a 3T MRI scan as well as a dynamic contrast-enhanced CT scan within one week prior to the start of treatment. Patients will also undergo a research 3T MRI scan and research dynamic contrast-enhanced CT scan at the one week post radiotherapy mark. An MRI scan during their 3 month post-treatment follow up visits will take place as per routine standard of care.

Group Type OTHER

CT and MRI Scans

Intervention Type DIAGNOSTIC_TEST

CT and MRI scans will occur before and after radiation therapy.

Interventions

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CT and MRI Scans

CT and MRI scans will occur before and after radiation therapy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
* At least one index lesion with diameter \> 1cm and without imaging evidence of hemorrhage
* Patients age \> 18 years of age
* Patients planned for RT to brain metastases
* Ability to understand and the willingness to sign a written informed consent document.