Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05124912

REMASTer: REcurrent Brain Metastases After SRS Trial

Led by Monteris Medical · Updated on 2026-02-20

261

Participants Needed

9

Research Sites

333 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

REMASTer: REcurrent Brain Metastases After SRS Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with radiographically proven brain metastases from confirmed non-CNS cancer
  • Patients with a measurable, targetable intracranial lesion recurrent after SRS with or without surgery
  • Lesion must show at least 25% size increase after prior treatment
  • At least 3 months have passed since initial SRS treatment of the target lesion
  • Lesion must be suitable for surgical biopsy and LITT as determined by neurosurgeon
  • Frozen pathology diagnosis must be possible
  • Patient must be symptomatically stable for at least 3 days prior to procedure on a steroid dose equivalent to 4mg dexamethasone or less daily
  • Age 18 years or older
  • Karnofsky Performance Status of 70 or higher
  • Ability and willingness to complete study requirements
  • Adequate blood counts: ANC 21.5 x 10^9/L and platelets 100 x 10^9/L within 4 weeks before biopsy
  • Serum creatinine less than 1.5 times upper limit of normal within 4 weeks before biopsy
  • Negative pregnancy test for females of reproductive potential unless postmenopausal or surgically sterile
  • Agreement to use effective contraception during the study if of reproductive potential
  • Accessibility for follow-up
Not Eligible

You will not qualify if you...

  • More than 3 progressing brain lesions at enrollment
  • New intracranial metastases concurrent with the target lesion
  • Use of bevacizumab within 4 weeks before study start
  • Concurrent cancers requiring active treatment except non-melanoma skin cancer or in-situ cervical cancer
  • Serious active infection or other medical conditions impairing ability to complete study assessments
  • Contraindication or intolerance to steroid therapy
  • Ineligibility or inability to tolerate SRS treatment
  • Conditions preventing surgical procedures as judged by physicians
  • Unwillingness or inability to consent or comply with study requirements
  • Diffuse leptomeningeal disease
  • Rapidly progressing extracranial disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

2

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

3

University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

4

WashU

St Louis, Missouri, United States, 63130

Actively Recruiting

5

Duke University Hospital

Durham, North Carolina, United States, 27710

Active, Not Recruiting

6

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

7

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

8

Kettering Health

Kettering, Ohio, United States, 45429

Actively Recruiting

9

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

C

Christa Seligman

CONTACT

K

Kate Weed

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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