Treatment Response Assessment Maps (TRAMs) in the Delineation of Radiation Necrosis From Tumor Progression After Stereotactic Radiation in Patients With Brain Metastases: A Prospective Study
Summary
This research study is investigating the value of an imaging study of the brain called an MRI (which stands for magnetic resonance imaging), utilized in unique way, to delineate whether the tumor has recurred or whether radiation changes have occurred after a brain metastasis treated with focused radiation has enlarged.
Detailed description
This research study is a Phase II clinical trial. In this research study, the investigators are utilizing MRIs of the brain with additional post-imaging processing (called Treatment Response Assessment Maps or TRAMs) to try to delineate tumor recurrence from radiation changes. The investigators hope to understand whether such a test may allow future patients to avoid resection entirely.
Arms & interventions
- DeviceMRI
Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.
Outcome measures
Primary
Sensitivity
The sensitivity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review
Time frame: Within 3 months of study enrollment
Secondary
Specificity
Time frame: Within 3 months of study enrollment
Positive predictive value
Time frame: Within 3 months of study enrollment
Negative predictive value
Time frame: Within 3 months of study enrollment
Eligibility criteria
Study locations (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115