MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Not Applicable

Recruiting

• Conditions: Brain Metastases
• Interventions: Other: MRI

• Registration Number: NCT04246879
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Study Start: 2021-07-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	MRI	-

Primary Outcome Measures

Name	Time	Method
number of positive MRI sequences along with positive tumor biopsies	baseline	true tumor will be detected by delayed MRI as determined by biopsy
number of negative MRI sequences along with negative tumor biopsies	baseline	absence of tumor will be detected by delayed MRI as determined by biopsy

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States