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

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)

Facility	City	Region	Status
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

GammaTile and Stupp in Newly Diagnosed GBM Active, not recruiting

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

Other trials for the same condition

MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors Active, not recruiting

Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets 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) 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