MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

May 4, 2026 updated by: Duke University

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI
Other: MRI
Subjects undergo one additional delayed MRI sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of positive MRI sequences along with positive tumor biopsies
Time Frame: baseline
true tumor will be detected by delayed MRI as determined by biopsy
baseline
number of negative MRI sequences along with negative tumor biopsies
Time Frame: baseline
absence of tumor will be detected by delayed MRI as determined by biopsy
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Scott Floyd, M.D. Ph.D., Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Actual)

March 19, 2025

Study Completion (Estimated)

March 24, 2027

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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