NCT04033497

Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
DEVICE	MRI	Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.

Timeline

• Start date: 2019-08-20
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2019-07-26
• Last updated: 2026-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study