MRI Following Stereotactic Radiosurgery (SRS) for Brain M... | NCT04246879

Studies
MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

NCT04246879

Sponsor

Duke University

Status

Active, not recruiting

Last Update Posted

May 6, 2026Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Brain Metastases

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2021Actual

Primary Completion Date

Mar 19, 2025Actual

Completion Date

Mar 24, 2027Estimated

First Submitted Date

Jan 28, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
MRI	Experimental		Other: MRI

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other	Subjects undergo one additional delayed MRI sequence	MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Floyd, M.D. Ph.D.	Duke Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Health System		Durham	North Carolina	27710	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided