REMASTer: REcurrent Brain Metastases After SRS Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
Monteris Medical
Study ID
NCT05124912
Status
Recruiting
Apply to this trial

Conditions

  • Brain Metastases
  • Radiation Necrosis
  • Recurrent Metastases
  • Recurrent Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — PROCEDURE
    Post-op hypofractionated therapy or no radiation therapy
  • Steroid Therapy — DRUG
    Best medical management with steroid therapy
  • Laser Interstitial Thermal Therapy — PROCEDURE
    Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)

Study Details

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.

Key Dates

Start date
May 10, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
261 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Recurrent Tumor
    Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
  • Other: Radiation Necrosis
    Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Primary Outcome Measure

Progressive Disease Cohort [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Emma Billingslea-Yoon
[email protected]
Won Kim, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Agnieszka Stadnik
[email protected]
Justine Lee
[email protected]
Peter Warnke, MD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Megan Camara
[email protected]
Mark Mishra, MD (PRINCIPAL_INVESTIGATOR)
WashUSt LouisMissouri63130
Albert Kim, MD, PhD (PRINCIPAL_INVESTIGATOR)
Duke University HospitalDurhamNorth Carolina27710-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Wendy Jenkins
[email protected]
Adrian Laxton, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Kayla Alejandro
[email protected]
Matthew Grabowski, MD (PRINCIPAL_INVESTIGATOR)
Kettering HealthKetteringOhio45429
Daniel Geyer
[email protected]
Mark Hoeprich, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Kaitlin Goetschel
[email protected]
Sarah Cornell
[email protected]
Max Krucoff, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CAUniversity of Chicago· Chicago, ILUniversity of Maryland· Baltimore, MDWashU· St Louis, MODuke University Hospital· Durham, NCWake Forest Baptist Medical Center· Winston-Salem, NC

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