MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

NCT ID: NCT04246879

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2027-03-19

Brief Summary

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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

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Conditions

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Brain Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MRI

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

Subjects undergo one additional delayed MRI sequence

Interventions

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MRI

Subjects undergo one additional delayed MRI sequence

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Floyd, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00103163

Identifier Type: -

Identifier Source: org_study_id

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