RecruitingNot ApplicableNCT05124912

REMASTer: REcurrent Brain Metastases After SRS Trial


Sponsor

Monteris Medical

Enrollment

261 participants

Start Date

May 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (REMASTer) is studying a minimally invasive brain procedure called laser interstitial thermal therapy (LITT) — which uses a laser probe to heat and destroy tumors — for brain metastases that have grown back after previous stereotactic radiosurgery (SRS). It aims to find out whether LITT can effectively treat these recurrent lesions with less risk than repeat radiation or open surgery. **You may be eligible if...** - You have brain metastases from a confirmed non-brain primary cancer (e.g., lung, breast, melanoma) - A specific lesion has clearly grown back (at least 25% larger) after previous SRS treatment - The target lesion is no more than 3 cm in its widest dimension and surgically accessible for the LITT probe - You are at least 3 months past your initial SRS treatment of the target spot - Your overall health allows surgery **You may NOT be eligible if...** - Your primary cancer is a brain tumor itself - Your lesion is not accessible for LITT treatment - You have signs of severe brain pressure or swelling requiring urgent open surgery - You have too many brain metastases (not suitable for focal treatment) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadiation Therapy

Post-op hypofractionated therapy or no radiation therapy

DRUGSteroid Therapy

Best medical management with steroid therapy

PROCEDURELaser Interstitial Thermal Therapy

Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)


Locations(9)

UCLA

Los Angeles, California, United States

University of Chicago

Chicago, Illinois, United States

University of Maryland

Baltimore, Maryland, United States

WashU

St Louis, Missouri, United States

Duke University Hospital

Durham, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Kettering Health

Kettering, Ohio, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05124912


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