MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
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ClinicalTrials.gov Identifier: NCT04246879 |
Recruitment Status :
Recruiting
First Posted : January 29, 2020
Last Update Posted : July 15, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Metastases | Other: MRI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 37 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases |
Actual Study Start Date : | July 19, 2021 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: MRI |
Other: MRI
Subjects undergo one additional delayed MRI sequence |
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 LITT procedure 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246879
Contact: Joan Cahill, BNS RN OCN CCRP | 919 668 5211 | joan.cahill@duke.edu |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Eileen Duffy, BNS OCN CCRP 919-668-3726 | |
Principal Investigator: Scott Floyd, MD PhD |
Principal Investigator: | Scott Floyd, M.D. Ph.D. | Duke Health |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04246879 |
Other Study ID Numbers: |
Pro00103163 |
First Posted: | January 29, 2020 Key Record Dates |
Last Update Posted: | July 15, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Laser Interstitial Thermal Therapy (LITT) Stereotactic radiosurgery (SRS) Magnetic resonance image (MRI) |
Neoplasm Metastasis Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |