Brain Imaging Biomarkers in Patients With Brain Metastasis

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT04197297

Collaborator

(none)

Enrollment

Location

Arm

38.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Brain Metastases, Adult	Diagnostic Test: CT and MRI Scans	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Diagnostic Test: CT and MRI Scans CT and MRI scans will occur before and after radiation therapy.

Arm

Intervention/Treatment

Other: 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.

Diagnostic Test: CT and MRI Scans

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

Outcome Measures

Primary Outcome Measures

Response Assessment in Neuro-Oncology (RANO) to validate biomarkers [Up to 2 years.]
Using RANO to validate imaging predictive biomarkers of response to radiotherapy
Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers [Up to 2 years.]
Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy
Progression Free Survival (PFS) to validate biomarkers [Up to 2 years.]
Using PFS to validate imaging predictive biomarkers of response to radiotherapy

Secondary Outcome Measures

Objective (Radiological) Progression [Up to 2 years.]
Defined as increase in volume of contrast uptake on MRI of > 25% as measured by two perpendicular tumor diameters compared to the smallest measurement ever for the same lesion by the same technique.
Objective (Radiological) Response [Up to 2 years.]
Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).
Time to Intracranial Local Progression [Up to 2 years.]
Defined as the time interval between the date of first treatment and the date of objective radiological progression of any one of the treated lesions.
Time to Intracranial Distant Progression [Up to 2 years.]
Defined as the time interval between the date of first treatment and the date of new brain metastases, with or without progression of the treated lesions.
Brain Progression Free Survival [Up to 2 years.]
Defined as the time interval between the date of first treatment and the date of disease progression in the brain or death due to disease in the brain, whichever comes first.
Unexpected and/or Serious Toxicities (AEs) [Up to 2 years.]
AEs that are deemed by the PI to be possibly, probably or definitely attributable to the research MRI and/or CT will be reported according to CTCAE version 4.3.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.