Recruiting

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

Sponsor:

GT Medical Technologies, Inc.

Code:

NCT04427384

Conditions

Brain Tumor, Recurrent

Brain Tumor

Brain Tumor, Primary

Brain Tumor - Metastatic

Brain Tumor, Adult: Glioblastoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

GammaTile

Study Details

Brief 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.

Conditions

Brain Tumor, Recurrent

Brain Tumor

Brain Tumor, Primary

Brain Tumor - Metastatic

Brain Tumor, Adult: Glioblastoma

Study ID

NCT04427384

Start date

Sep 11, 2020

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

GammaTile

Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.

Interventions

GammaTile

Surgically Targeted Radiation Therapy

Primary outcome measure

Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects [ Time Frame: 12 months ]
Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects [ Time Frame: 3 years ]
Overall Survival in High Grade Glioma Subjects [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Michael A. Garcia, MD, MS

(833) 662-0044 mgarcia@gtmedtech.com

Sita Patel, PhD, PharmD

(833)662-0044 spatel@gtmedtech.com

Locations

HonorHeath Scottsdale Osborn Medical Center

Recruiting

Phoenix, Arizona, United States, 85027

Principal Investigator:

John Wanebo, MD

University of Arkansas Medical Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Analiz Rodriguez, MD, PhD

501-296-1138

Eden Medical Center

Recruiting

Castro Valley, California, United States, 94546

Contacts

Lawrence Dickinson, MD

925-884-2360

Principal Investigator:

Lawrence Dickinson, MD

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Principal Investigator:

David Piccioni, MD, PhD

MemorialCare Health System

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Linda Chan, MD

562-933-0900 lchan@memorialcare.org

Principal Investigator:

Linda Chan, MD

Desert Regional Medical Center

Recruiting

Palm Springs, California, United States, 92262

Contacts

Amir Lavaf, MD

760-416-4770

Principal Investigator:

Amir Lavaf, MD

California Pacific Medical Center, Sutter health

Recruiting

San Francisco, California, United States, 94109

Contacts

Lewis Leng, MD

415-600-0528

Principal Investigator:

Lewis Leng, MD

Colorado Brain & Spine Institute: Swedish Campus

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Vadim Tsvankin, MD

303-783-8844

BayCare Health

Recruiting

Clearwater, Florida, United States, 33756

Ascension St. Vincent's

Recruiting

Jacksonville, Florida, United States, 32204

Contacts

Amanda Lindewood

904-308-5761

Principal Investigator:

Aristotelis Filippidis, MD

Miami Cancer Institute, Baptist Health South Florida

Recruiting

Miami, Florida, United States, 33176

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Imran Mohiuddin, MD

407-303-2030

Principal Investigator:

Imran Mohiuddin, MD

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

813-844-7585

Cleveland Clinic Florida- Weston

Recruiting

Weston, Florida, United States, 33331

Contacts

Surabhi Ranjan, MD, FACP

954-659-5670

Principal Investigator:

Surabhi Ranjan, MD, FACP

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

St. Alphonsus Regional Medical Center

Recruiting

Boise, Idaho, United States, 83704

Goodman Campbell Brain and Spine

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Heather Cero

317-396-1448 hcero@goodmancampbell.com

Principal Investigator:

Kushal Shah, MD

Indiana University, IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

KUMC Dept of Neurosurgery

Recruiting

Kansas City, Kansas, United States, 66160

Univeristy of Louisville Health

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Akshitkumar Mistry, MD

502-588-2160

Principal Investigator:

Akshitkumar Mistry, MD

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40241

Contacts

Parag Sevak, MD

Parag.Sevak@nortonhealthcare.org

Principal Investigator:

Parag Sevak, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Rafael Vega, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Rafael Vega, MD

rvega@bidmc.harvard.edu

Principal Investigator:

Rafael Vega, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Principal Investigator:

Lindsey Sloan, MD, PhD

University of Nebraska

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Michele Aizenberg, MD

402-559-6704

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Tuba Ahmed

518-262-5088

Principal Investigator:

Alexandra Paul, MD

SUNY Upstate Medical Center

Recruiting

Syracuse, New York, United States, 13210

Contacts

Harish Babu, MD

315-464-4470

Principal Investigator:

Harish Babu, MD

Montefiore Einstein

Recruiting

The Bronx, New York, United States, 10467

Contacts

Genesis Liriano

718-920-4321

Principal Investigator:

Vijay Agarwal, MD

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Vidant Heath - ECU Medical Center

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Stuart Lee, MD

252-847-1550

Atlantic Brain & Spine

Recruiting

Wilmington, North Carolina, United States, 28401

Contacts

Bridgette Smith

b.smith@atlanticbrainandspine.com

Principal Investigator:

Jeffrey Beecher, DO

Mayfield Brain and Spine

Recruiting

Cincinnati, Ohio, United States, 45209

Contacts

Vincent DiNapoli, MD

513-888-7564

Kettering Health

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Mark Hoeprich, MD

937-298-4331

Principal Investigator:

Mark Hoeprich, MD

St Luke's University Health, Sacred Heart Campus

Recruiting

Allentown, Pennsylvania, United States, 18102

Principal Investigator:

William Smith, MD

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

Sean Mahase, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sarah Kimutis

412-359-3565 sarah.kimutis@ahn.org

Principal Investigator:

Matthew Shepard, MD

Brown University Health

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Clarck Chen, MD, PhD

401-793-9166 clark.chen@lifespan.org

Principal Investigator:

Clark Chen, MD, PhD

CHI Memorial Hospital, CommonSpirit

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Ginger Whisman

ginger.whisman@commonspirit.org

Principal Investigator:

Ranjith Babu, MD

UT Southwestern Simmons Cancer Center

Recruiting

Dallas, Texas, United States, 75235

Baylor St. Luke's Medical Center | Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Akash Patel, MD

713-798-8810

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

University of Texas Health Science Center of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Texas Oncology-The Woodlands

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

James Zhu, M.D., Ph.D.

james.zhu@usoncology.com

Principal Investigator:

James Zhu, M.D., Ph.D

INOVA Health

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Daniel Kim, MD

571-472-0606

Principal Investigator:

Daniel Kim, MD

Virginia Mason

Recruiting

Seattle, Washington, United States, 98101

Contacts

Huong Pham, MD

206-287-6278

Principal Investigator:

Huong Pham, MD

More Information

Sponsor

GT Medical Technologies, Inc.

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by GT Medical Technologies, Inc. on 2026-07-22.