MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Brain Metastases Clinical Trial

Official title:

Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246879
• Other study ID #: Pro00103163
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Eileen Duffy, RN OCN
• Phone: 919 668 3726
• Email: eileen.duffy[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• MRI
Subjects undergo one additional delayed MRI sequence

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of positive MRI sequences along with positive tumor biopsies	true tumor will be detected by delayed MRI as determined by biopsy	baseline
Primary	number of negative MRI sequences along with negative tumor biopsies	absence of tumor will be detected by delayed MRI as determined by biopsy	baseline