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

NCT ID: NCT04427384

Last Updated: 2026-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-11

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

Conditions

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Brain Tumor, Recurrent Brain Tumor Brain Tumor, Primary Brain Tumor - Metastatic Brain Tumor, Adult: Glioblastoma Brain Tumor, Adult Meningioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GammaTile

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

GammaTile

Intervention Type DEVICE

Surgically Targeted Radiation Therapy

Interventions

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GammaTile

Surgically Targeted Radiation Therapy

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GT Medical Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A. Garcia, MD, MS

Role: STUDY_DIRECTOR

GT Medical Technologies

Locations

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HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona, United States

Site Status RECRUITING

University of Arkansas Medical Center

Little Rock, Arkansas, United States

Site Status RECRUITING

Eden Medical Center

Castro Valley, California, United States

Site Status RECRUITING

UCSD Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

MemorialCare Health System

Laguna Hills, California, United States

Site Status RECRUITING

Desert Regional Medical Center

Palm Springs, California, United States

Site Status RECRUITING

California Pacific Medical Center, Sutter health

San Francisco, California, United States

Site Status RECRUITING

Centura

Denver, Colorado, United States

Site Status NOT_YET_RECRUITING

Colorado Brain & Spine Institute: Swedish Campus

Englewood, Colorado, United States

Site Status RECRUITING

BayCare Health

Clearwater, Florida, United States

Site Status RECRUITING

Ascension St. Vincent's

Jacksonville, Florida, United States

Site Status RECRUITING

Miami Cancer Institute, Baptist Health South Florida

Miami, Florida, United States

Site Status RECRUITING

Advent Health Orlando

Orlando, Florida, United States

Site Status RECRUITING

Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

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

Tampa, Florida, United States

Site Status RECRUITING

Cleveland Clinic Florida- Weston

Weston, Florida, United States

Site Status RECRUITING

Piedmont Healthcare

Atlanta, Georgia, United States

Site Status RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

St. Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status RECRUITING

Goodman Campbell Brain and Spine

Carmel, Indiana, United States

Site Status RECRUITING

Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

KUMC Dept of Neurosurgery

Kansas City, Kansas, United States

Site Status RECRUITING

Univeristy of Louisville Health

Louisville, Kentucky, United States

Site Status RECRUITING

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status RECRUITING

Willis-Knighton Medical Center

Shreveport, Louisiana, United States

Site Status WITHDRAWN

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Nebraska

Omaha, Nebraska, United States

Site Status RECRUITING

Clinical Research dep. Davison Place. Englewood Health

Englewood, New Jersey, United States

Site Status NOT_YET_RECRUITING

Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

SUNY Upstate Medical Center

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Einstein

The Bronx, New York, United States

Site Status RECRUITING

Westchester Medical Center

Valhalla, New York, United States

Site Status RECRUITING

University of North Carolina Health

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Vidant Heath - ECU Medical Center

Greenville, North Carolina, United States

Site Status RECRUITING

Atlantic Brain & Spine

Wilmington, North Carolina, United States

Site Status RECRUITING

Mayfield Brain and Spine

Cincinnati, Ohio, United States

Site Status RECRUITING

Kettering Health

Kettering, Ohio, United States

Site Status RECRUITING

St Luke's University Health, Sacred Heart Campus

Allentown, Pennsylvania, United States

Site Status RECRUITING

Penn State Health

Hershey, Pennsylvania, United States

Site Status RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Brown University Health

Providence, Rhode Island, United States

Site Status RECRUITING

CHI Memorial Hospital, CommonSpirit

Chattanooga, Tennessee, United States

Site Status RECRUITING

UT Southwestern Simmons Cancer Center

Dallas, Texas, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center of San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Texas Oncology-The Woodlands

The Woodlands, Texas, United States

Site Status RECRUITING

INOVA Health

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Mason

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael A. Garcia, MD, MS

Role: CONTACT

(833) 662-0044

Sita Patel, PhD, PharmD

Role: CONTACT

(833)662-0044

Facility Contacts

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John Wanebo, MD

Role: primary

Analiz Rodriguez, MD, PhD

Role: primary

501-296-1138

Lawrence Dickinson, MD

Role: primary

925-884-2360

David Piccioni, MD, PhD

Role: primary

Linda Chan, MD

Role: primary

562-933-0900

Amir Lavaf, MD

Role: primary

760-416-4770

Lewis Leng, MD

Role: primary

415-600-0528

Angela Bohnen, MD

Role: primary

Vadim Tsvankin, MD

Role: primary

303-783-8844

Devon Haydon, MD

Role: primary

Amanda Lindewood

Role: primary

904-308-5761

Rupesh Kotecha, MD

Role: primary

Imran Mohiuddin, MD

Role: primary

407-303-2030

Catherine Mercado, MD

Role: primary

Tulika Ranjan, MD

Role: primary

Role: backup

813-844-7585

Surabhi Ranjan, MD, FACP

Role: primary

954-659-5670

Adam Nowlan, MD

Role: primary

Kimberly Bojanowski

Role: primary

Ondrej Choutka

Role: primary

Heather Cero

Role: primary

317-396-1448

Mitesh Shah

Role: primary

Kushal Shah

Role: primary

Akshitkumar Mistry, MD

Role: primary

502-588-2160

Parag Sevak, MD

Role: primary

Stephen Duggan

Role: primary

Rafael Vega, MD

Role: primary

Adam M Robin, MD

Role: primary

John Trusheim, MD

Role: primary

Lindsey Sloan, MD, PhD

Role: primary

Michele Aizenberg, MD

Role: primary

402-559-6704

Kevin Yao, MD

Role: primary

Dubin David, MD

Role: backup

Tuba Ahmed

Role: primary

518-262-5088

Harish Babu, MD

Role: primary

315-464-4470

Genesis Liriano

Role: primary

718-920-4321

Simon Hanft

Role: primary

Colette Shen, MD

Role: primary

Stuart Lee, MD

Role: primary

252-847-1550

Bridgette Smith

Role: primary

Vincent DiNapoli, MD

Role: primary

513-888-7564

Mark Hoeprich, MD

Role: primary

937-298-4331

William Smith, MD

Role: primary

Rachel Horstman

Role: primary

Sarah Kimutis

Role: primary

412-359-3565

Clarck Chen, MD, PhD

Role: primary

401-793-9166

Ginger Whisman

Role: primary

Toral Patel, MD

Role: primary

Akash Patel, MD

Role: primary

713-798-8810

David Baskin, MD

Role: primary

John Floyd, MD

Role: primary

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

Role: primary

Daniel Kim, MD

Role: primary

571-472-0606

Huong Pham, MD

Role: primary

206-287-6278

Other Identifiers

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GTM-101

Identifier Type: -

Identifier Source: org_study_id

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