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Clinical Trials in the USA / NCT04427384
Recruiting Observational

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

NCT04427384 · tracked via the Priya Life Science USA tracker
Sponsor
GT Medical Technologies, Inc
Phase
Observational
Started
2020-09-11
Last updated
2026-07-22

Condition(s) studied

Brain Tumor, RecurrentBrain TumorBrain Tumor, PrimaryBrain Tumor - MetastaticBrain Tumor, Adult: GlioblastomaBrain Tumor, Adult Meningioma

Investigational drug(s) / intervention(s)

GammaTile

GammaTile: Surgically Targeted Radiation Therapy

Study summary

The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles. 2. Willing and able to provide informed consent and to participate in all evaluations. Exclusion Criteria: 1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment. 2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups. 3. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.

Primary outcome measure(s)

  • Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects — 12 months
    No contrast enhancement in the area of the surgical bed
  • Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects — 3 years
    No contrast enhancement in the area of the surgical bed
  • Overall Survival in High Grade Glioma Subjects — 9 months
    Median duration of survival of subjects following surgical resection of tumor

Trial sites (54)

FacilityCityRegionStatus
HonorHeath Scottsdale Osborn Medical Center Phoenix Arizona Recruiting
University of Arkansas Medical Center Little Rock Arkansas Recruiting
Eden Medical Center Castro Valley California Recruiting
UCSD Moores Cancer Center La Jolla California Recruiting
MemorialCare Health System Laguna Hills California Recruiting
Desert Regional Medical Center Palm Springs California Recruiting
California Pacific Medical Center, Sutter health San Francisco California Recruiting
Centura Denver Colorado Not Yet Recruiting
Colorado Brain & Spine Institute: Swedish Campus Englewood Colorado Recruiting
BayCare Health Clearwater Florida Recruiting
Ascension St. Vincent's Jacksonville Florida Recruiting
Miami Cancer Institute, Baptist Health South Florida Miami Florida Recruiting
Advent Health Orlando Orlando Florida Recruiting
Orlando Health Orlando Florida Recruiting
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital Tampa Florida Recruiting
Cleveland Clinic Florida- Weston Weston Florida Recruiting
Piedmont Healthcare Atlanta Georgia Recruiting
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
St. Alphonsus Regional Medical Center Boise Idaho Recruiting
Goodman Campbell Brain and Spine Carmel Indiana Recruiting
Indiana University, IU Health Methodist Hospital Indianapolis Indiana Recruiting
KUMC Dept of Neurosurgery Kansas City Kansas Recruiting
Univeristy of Louisville Health Louisville Kentucky Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
Willis-Knighton Medical Center Shreveport Louisiana Withdrawn
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Abbott Northwestern Hospital Minneapolis Minnesota Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
University of Nebraska Omaha Nebraska Recruiting
Clinical Research dep. Davison Place. Englewood Health Englewood New Jersey Not Yet Recruiting
Albany Medical Center Albany New York Recruiting
Mount Sinai Hospital New York New York Active Not Recruiting
SUNY Upstate Medical Center Syracuse New York Recruiting
Montefiore Einstein The Bronx New York Recruiting
Westchester Medical Center Valhalla New York Recruiting
University of North Carolina Health Chapel Hill North Carolina Active Not Recruiting
Vidant Heath - ECU Medical Center Greenville North Carolina Recruiting
Atlantic Brain & Spine Wilmington North Carolina Recruiting

+ 14 more sites — see the full list on the official registry below.

More GT Medical Technologies, Inc. trials in the USA

Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study) Active, not recruiting
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care Recruiting
GammaTile and Stupp in Newly Diagnosed GBM Active, not recruiting

Other trials for the same condition

MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors Active, not recruiting
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG). Recruiting
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets Recruiting
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04427384 on ClinicalTrials.gov ↗ ← All trials in the USA