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NCT04427384Recruiting

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

GT Medical Technologies, Inc.

Start Date

9/11/2020

Completion Date

12/31/2028

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.

Detailed 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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DEVICE

GammaTile

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Conditions

Brain Tumor, RecurrentBrain TumorBrain Tumor, PrimaryBrain Tumor - MetastaticBrain Tumor, Adult: GlioblastomaBrain Tumor, Adult Meningioma

Locations

HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona 85027

United States

University of Arkansas Medical Center

Little Rock, Arkansas 72205

United States

Eden Medical Center

Castro Valley, California 94546

United States

UCSD Moores Cancer Center

La Jolla, California 92093

United States

MemorialCare Health System

Laguna Hills, California 92653

United States

Desert Regional Medical Center

Palm Springs, California 92262

United States

California Pacific Medical Center, Sutter health

San Francisco, California 94109

United States

Centura

Denver, Colorado 80201

United States

Colorado Brain & Spine Institute: Swedish Campus

Englewood, Colorado 80113

United States

BayCare Health

Clearwater, Florida 33756

United States

Ascension St. Vincent's

Jacksonville, Florida 32204

United States

Miami Cancer Institute, Baptist Health South Florida

Miami, Florida 33176

United States

Advent Health Orlando

Orlando, Florida 32803

United States

Orlando Health

Orlando, Florida 32806

United States

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

Tampa, Florida 33606

United States

Cleveland Clinic Florida- Weston

Weston, Florida 33331

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

United States

St. Alphonsus Regional Medical Center

Boise, Idaho 83704

United States

Goodman Campbell Brain and Spine

Carmel, Indiana 46032

United States

Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana 46202

United States

KUMC Dept of Neurosurgery

Kansas City, Kansas 66160

United States

Univeristy of Louisville Health

Louisville, Kentucky 40202

United States

Norton Cancer Institute

Louisville, Kentucky 40241

United States

Willis-Knighton Medical Center

Shreveport, Louisiana 71103

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

University of Minnesota

Minneapolis, Minnesota 55414

United States

University of Nebraska

Omaha, Nebraska 68198

United States

Clinical Research dep. Davison Place. Englewood Health

Englewood, New Jersey 07631

United States

Albany Medical Center

Albany, New York 12208

United States

Mount Sinai Hospital

New York, New York 10029

United States

SUNY Upstate Medical Center

Syracuse, New York 13210

United States

Montefiore Einstein

The Bronx, New York 10467

United States

Westchester Medical Center

Valhalla, New York 10595

United States

University of North Carolina Health

Chapel Hill, North Carolina 27599

United States

Vidant Heath - ECU Medical Center

Greenville, North Carolina 27834

United States

Atlantic Brain & Spine

Wilmington, North Carolina 28401

United States

Mayfield Brain and Spine

Cincinnati, Ohio 45209

United States

Kettering Health

Kettering, Ohio 45429

United States

St Luke's University Health, Sacred Heart Campus

Allentown, Pennsylvania 18102

United States

Penn State Health

Hershey, Pennsylvania 17033

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Brown University Health

Providence, Rhode Island 02906

United States

CHI Memorial Hospital, CommonSpirit

Chattanooga, Tennessee 37404

United States

UT Southwestern Simmons Cancer Center

Dallas, Texas 75235

United States

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

Houston, Texas 77030

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

University of Texas Health Science Center of San Antonio

San Antonio, Texas 78229

United States

Texas Oncology-The Woodlands

The Woodlands, Texas 77380

United States

INOVA Health

Fairfax, Virginia 22031

United States

Virginia Mason

Seattle, Washington 98101

United States