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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
90
CT and MRI scans will occur before and after radiation therapy.
University Health Network
Toronto, Ontario, Canada
RECRUITINGResponse Assessment in Neuro-Oncology (RANO) to validate biomarkers
Using RANO to validate imaging predictive biomarkers of response to radiotherapy
Time frame: Up to 2 years.
Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers
Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy
Time frame: Up to 2 years.
Progression Free Survival (PFS) to validate biomarkers
Using PFS to validate imaging predictive biomarkers of response to radiotherapy
Time frame: Up to 2 years.
Objective (Radiological) Progression
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.
Time frame: Up to 2 years.
Objective (Radiological) Response
Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).
Time frame: Up to 2 years.
Time to Intracranial Local Progression
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 frame: Up to 2 years.
Time to Intracranial Distant Progression
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.
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Time frame: Up to 2 years.
Brain Progression Free Survival
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.
Time frame: Up to 2 years.
Unexpected and/or Serious Toxicities (AEs)
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.
Time frame: Up to 2 years.