MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2020
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedStudy Start
First participant enrolled
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2027
ExpectedMay 6, 2026
May 1, 2026
3.7 years
January 28, 2020
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
number of positive MRI sequences along with positive tumor biopsies
true tumor will be detected by delayed MRI as determined by biopsy
baseline
number of negative MRI sequences along with negative tumor biopsies
absence of tumor will be detected by delayed MRI as determined by biopsy
baseline
Study Arms (1)
MRI
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Health System
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Floyd, M.D. Ph.D.
Duke Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2020
First Posted
January 29, 2020
Study Start
July 19, 2021
Primary Completion
March 19, 2025
Study Completion (Estimated)
March 24, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share