Actively Recruiting
A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy in Intracranial Brain Tumors
Led by GT Medical Technologies, Inc. · Updated on 2026-02-13
600
Participants Needed
54
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational registry study focuses on patients with brain tumors of various types who have undergone surgical removal of their tumors followed by Surgically Targeted Radiation Therapy (STaRT) using GammaTile. The study aims to collect real-world data on clinical outcomes and patient-reported measures to understand the effectiveness and safety of this treatment approach. It is sponsored by GT Medical Technologies, Inc., and is designed to compare outcomes against standard treatments in a real-world setting. The intervention involves the permanent implantation of GammaTile radiation therapy tiles, which deliver targeted radiation immediately after tumor surgery. These tiles contain Cesium-131 sources embedded in resorbable collagen carriers. The study includes patients who have received this implant following their brain tumor resection and monitors their progress over time. Participants will be followed closely with data collection at 1, 3, 6, 9, 12, 18, and 24 months, and then every 6 months up to 5 years. Researchers will evaluate local tumor control, overall survival, quality of life, neurocognitive function, functional decline, and any adverse events related to surgery or radiation. Key outcomes include surgical bed-recurrence-free survival for metastatic and meningioma tumors, and overall survival for high-grade gliomas. This long-term monitoring helps assess both potential risks and benefits of STaRT in everyday clinical practice.
CONDITIONS
Brief Title
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone maximum safe surgical removal of an intracranial brain tumor and implantation of GammaTiles.
- Willing and able to provide informed consent.
- Able to participate in all required evaluations.
You will not qualify if you...
- Unable to undergo pre-operative and post-operative imaging for disease and implant assessment.
- Having major medical or psychiatric illness that would prevent completion of treatment or follow-up assessments.
- Unable to understand the study protocol or provide informed consent, including those with history of poor cooperation or noncompliance with medical treatment, or difficulty returning for follow-up care. A legally authorized representative may consent if the participant lacks capacity.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day of surgery
Participants undergo surgical resection of their brain tumor followed by implantation of GammaTile radiation therapy.
1 surgery and implantation visit (in-person)
Duration - Up to 5 years
Participants are monitored for clinical outcomes including local control, overall survival, quality of life, neurocognition, functional decline, and treatment-related adverse events.
Visits at 1, 3, 6, 9, 12, 18, and 24 months, then every 6 months through 5 years
Trial Site Locations
Total: 54 locations
1
HonorHeath Scottsdale Osborn Medical Center
Phoenix, Arizona, United States, 85027
Actively Recruiting
2
University of Arkansas Medical Center
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Eden Medical Center
Castro Valley, California, United States, 94546
Actively Recruiting
4
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
5
MemorialCare Health System
Laguna Hills, California, United States, 92653
Actively Recruiting
6
Desert Regional Medical Center
Palm Springs, California, United States, 92262
Actively Recruiting
7
California Pacific Medical Center, Sutter health
San Francisco, California, United States, 94109
Actively Recruiting
8
Centura
Denver, Colorado, United States, 80201
Not Yet Recruiting
9
Colorado Brain & Spine Institute: Swedish Campus
Englewood, Colorado, United States, 80113
Actively Recruiting
10
BayCare Health
Clearwater, Florida, United States, 33756
Actively Recruiting
11
Ascension St. Vincent's
Jacksonville, Florida, United States, 32204
Actively Recruiting
12
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
13
Advent Health Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
14
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
15
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
16
Cleveland Clinic Florida- Weston
Weston, Florida, United States, 33331
Actively Recruiting
17
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
18
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
19
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83704
Actively Recruiting
20
Goodman Campbell Brain and Spine
Carmel, Indiana, United States, 46032
Actively Recruiting
21
Indiana University, IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
22
KUMC Dept of Neurosurgery
Kansas City, Kansas, United States, 66160
Actively Recruiting
23
Univeristy of Louisville Health
Louisville, Kentucky, United States, 40202
Actively Recruiting
24
Norton Cancer Institute
Louisville, Kentucky, United States, 40241
Actively Recruiting
25
Willis-Knighton Medical Center
Shreveport, Louisiana, United States, 71103
Withdrawn
26
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
27
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
28
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
29
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
30
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
31
University of Nebraska
Omaha, Nebraska, United States, 68198
Actively Recruiting
32
Clinical Research dep. Davison Place. Englewood Health
Englewood, New Jersey, United States, 07631
Not Yet Recruiting
33
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
34
Mount Sinai Hospital
New York, New York, United States, 10029
Active, Not Recruiting
35
SUNY Upstate Medical Center
Syracuse, New York, United States, 13210
Actively Recruiting
36
Montefiore Einstein
The Bronx, New York, United States, 10467
Actively Recruiting
37
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
38
University of North Carolina Health
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
39
Vidant Heath - ECU Medical Center
Greenville, North Carolina, United States, 27834
Actively Recruiting
40
Atlantic Brain & Spine
Wilmington, North Carolina, United States, 28401
Actively Recruiting
41
Mayfield Brain and Spine
Cincinnati, Ohio, United States, 45209
Actively Recruiting
42
Kettering Health
Kettering, Ohio, United States, 45429
Actively Recruiting
43
St Luke's University Health, Sacred Heart Campus
Allentown, Pennsylvania, United States, 18102
Actively Recruiting
44
Penn State Health
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
45
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
46
Brown University Health
Providence, Rhode Island, United States, 02906
Actively Recruiting
47
CHI Memorial Hospital, CommonSpirit
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
48
UT Southwestern Simmons Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
49
Baylor St. Luke's Medical Center | Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
50
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
51
University of Texas Health Science Center of San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
52
Texas Oncology-The Woodlands
The Woodlands, Texas, United States, 77380
Actively Recruiting
53
INOVA Health
Fairfax, Virginia, United States, 22031
Actively Recruiting
54
Virginia Mason
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
M
Michael A. Garcia, MD, MS
S
Sita Patel, PhD, PharmD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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