Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Duke University1 site in 1 country25 target enrollmentJuly 19, 2021

ConditionsBrain Metastases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Metastases
Sponsor: Duke University
Enrollment: 25
Locations: 1
Primary Endpoint: number of positive MRI sequences along with positive tumor biopsies
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).

Registry

clinicaltrials.gov

Start Date

July 19, 2021

End Date

March 19, 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, age ≥18
•Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
•Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
•Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
•Radiographic progression on post-SRS imaging at previously treated SRS site(s)
•Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
•Patients must sign study-specific informed consent prior to study entry

Exclusion Criteria

•Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
•Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
•Small cell lung cancer (SCLC) or lymphoma histology