MRI
DeviceMagnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.
NCT Number: NCT04033497
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brigham and Women's Hospital, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.
Time frame: Within 3 months of study enrollment
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
The specificity 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
The positive predictive value 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
The negative predictive value 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
Contact information is provided by the study sponsor or research team.
Ayal Aizer, MD, MHS
CONTACT
Ivy Ricca, BA
CONTACT
Brigham and Women's Hospital
Other
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
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