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

Last updated: February 26, 2025
Sponsor: GT Medical Technologies, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Tumor

Brain Cancer

Memory Loss

Treatment

GammaTile

Clinical Study ID

NCT04427384
GTM-101
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients who undergo maximum safe resection of intracranial neoplasm(s) ANDimplantation of GammaTiles.

  2. Willing and able to provide informed consent and to participate in all evaluations.

Exclusion

Exclusion Criteria:

  1. Inability to undergo pre-operative and post-operative imaging for disease andimplant assessment.

  2. Major medical or psychiatric illness, which, in the investigator's opinion wouldprevent completion of treatment, ability to complete assessments at the time ofenrollment, and/or interfere with follow ups.

  3. Lack of English language fluency sufficient to allow for completion ofneurocognitive and QOL tests (which are in English).

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: GammaTile
Phase:
Study Start date:
September 11, 2020
Estimated Completion Date:
December 31, 2028

Study Description

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.

Connect with a study center

  • Banner MD Anderson

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • HonorHealth Research Institute

    Phoenix, Arizona 85027
    United States

    Active - Recruiting

  • HonorHeath Scottsdale Osborn Medical Center

    Phoenix, Arizona 85027
    United States

    Active - Recruiting

  • University of Arkansas Medical Center

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Eden Medical Center

    Castro Valley, California 94546
    United States

    Active - Recruiting

  • UCSD Moores Cancer Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • MemorialCare Health System

    Laguna Hills, California 92653
    United States

    Active - Recruiting

  • Desert Regional Medical Center

    Palm Springs, California 92262
    United States

    Active - Recruiting

  • California Pacific Medical Center, Sutter health

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Sutter health

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Centura

    Denver, Colorado 80201
    United States

    Site Not Available

  • Colorado Brain & Spine Institute: Swedish Campus

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • BayCare Health

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Miami Cancer Institute, Baptist Health South Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Orlando Health

    Orlando, Florida 32806
    United States

    Active - Recruiting

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

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Cleveland Clinic Florida- Weston

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • St. Alphonsus Regional Medical Center

    Boise, Idaho 83704
    United States

    Active - Recruiting

  • Indiana University, IU Health Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • KUMC Dept of Neurosurgery

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Univeristy of Louisville Health

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Willis-Knighton Medical Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

  • University of Nebraska

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Clinical Research dep. Davison Place. Englewood Health

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • SUNY Upstate Medical Center

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • University of North Carolina Health

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Vidant

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Vidant Heath - ECU Medical Center

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Atlantic Brain & Spine

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Mayfield Brain and Spine

    Cincinnati, Ohio 45209
    United States

    Active - Recruiting

  • Kettering Health

    Kettering, Ohio 45429
    United States

    Active - Recruiting

  • St Luke's University Health, Sacred Heart Campus

    Allentown, Pennsylvania 18102
    United States

    Active - Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Brown University Health

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • CHI Memorial Hospital, CommonSpirit

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • UT Southwestern Simmons Cancer Center

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Baylor St. Luke's Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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

    Houston, Texas 77030
    United States

    Active - Recruiting

  • CHI Baylor St. Luke's Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The Methodist Hospital Research Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center of San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Texas Oncology-The Woodlands

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • INOVA Health

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Mason

    Seattle, Washington 98101
    United States

    Active - Recruiting

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