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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04427384
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GT Medical Technologies, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael A. Garcia, MD, MS
Principal Investigator Affiliation GT Medical Technologies
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

: GammaTile

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

Interventions

Device: - GammaTile

Surgically Targeted Radiation Therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona, 85027

Site Contact

John Wanebo, MD

[email protected]

(833) 662-0044

University of Arkansas Medical Center, Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas Medical Center

Little Rock, Arkansas, 72205

Site Contact

Analiz Rodriguez, MD, PhD

[email protected]

501-296-1138

Eden Medical Center, Castro Valley, California

Status

Recruiting

Address

Eden Medical Center

Castro Valley, California, 94546

Site Contact

Lawrence Dickinson, MD

[email protected]

925-884-2360

UCSD Moores Cancer Center, La Jolla, California

Status

Recruiting

Address

UCSD Moores Cancer Center

La Jolla, California, 92093

Site Contact

David Piccioni, MD, PhD

[email protected]

(833) 662-0044

Desert Regional Medical Center, Palm Springs, California

Status

Recruiting

Address

Desert Regional Medical Center

Palm Springs, California, 92262

Site Contact

Amir Lavaf, MD

[email protected]

760-416-4770

San Francisco, California

Status

Recruiting

Address

California Pacific Medical Center, Sutter health

San Francisco, California, 94109

Site Contact

Lewis Leng, MD

[email protected]

415-600-0528

Centura, Denver, Colorado

Status

Not yet recruiting

Address

Centura

Denver, Colorado, 80201

Site Contact

Angela Bohnen, MD

[email protected]

(833) 662-0044

Englewood, Colorado

Status

Recruiting

Address

Colorado Brain & Spine Institute: Swedish Campus

Englewood, Colorado, 80113

Site Contact

Vadim Tsvankin, MD

[email protected]

303-783-8844

BayCare Health, Clearwater, Florida

Status

Recruiting

Address

BayCare Health

Clearwater, Florida, 33756

Site Contact

Devon Haydon, MD

[email protected]

(833) 662-0044

Miami, Florida

Status

Recruiting

Address

Miami Cancer Institute, Baptist Health South Florida

Miami, Florida, 33176

Site Contact

Rupesh Kotecha, MD

[email protected]

(833) 662-0044

Advent Health Orlando, Orlando, Florida

Status

Recruiting

Address

Advent Health Orlando

Orlando, Florida, 32803

Site Contact

Imran Mohiuddin, MD

[email protected]

407-303-2030

Orlando Health, Orlando, Florida

Status

Recruiting

Address

Orlando Health

Orlando, Florida, 32806

Site Contact

Catherine Mercado, MD

[email protected]

(833) 662-0044

Tampa, Florida

Status

Recruiting

Address

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

Tampa, Florida, 33606

Site Contact

Tulika Ranjan, MD

[email protected]

(833) 662-0044

Cleveland Clinic Florida- Weston, Weston, Florida

Status

Recruiting

Address

Cleveland Clinic Florida- Weston

Weston, Florida, 33331

Site Contact

Surabhi Ranjan, MD, FACP

[email protected]

954-659-5670

Piedmont Healthcare, Atlanta, Georgia

Status

Recruiting

Address

Piedmont Healthcare

Atlanta, Georgia, 30309

Site Contact

Adam Nowlan, MD

[email protected]

(833) 662-0044

Atlanta, Georgia

Status

Recruiting

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Site Contact

Kimberly Bojanowski

[email protected]

(833) 662-0044

St. Alphonsus Regional Medical Center, Boise, Idaho

Status

Recruiting

Address

St. Alphonsus Regional Medical Center

Boise, Idaho, 83704

Site Contact

Ondrej Choutka

[email protected]

(833) 662-0044

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana, 46202

Site Contact

Mitesh Shah

[email protected]

(833) 662-0044

KUMC Dept of Neurosurgery, Kansas City, Kansas

Status

Recruiting

Address

KUMC Dept of Neurosurgery

Kansas City, Kansas, 66160

Site Contact

Kushal Shah

[email protected]

(833) 662-0044

Univeristy of Louisville Health, Louisville, Kentucky

Status

Recruiting

Address

Univeristy of Louisville Health

Louisville, Kentucky, 40202

Site Contact

Akshitkumar Mistry, MD

[email protected]

502-588-2160

Norton Cancer Institute, Louisville, Kentucky

Status

Recruiting

Address

Norton Cancer Institute

Louisville, Kentucky, 40241

Site Contact

Parag Sevak, MD

[email protected]

(833) 662-0044

Willis-Knighton Medical Center, Shreveport, Louisiana

Status

Withdrawn

Address

Willis-Knighton Medical Center

Shreveport, Louisiana, 71103

Henry Ford Health System, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Health System

Detroit, Michigan, 48202

Site Contact

Adam M Robin, MD

[email protected]

(833) 662-0044

Abbott Northwestern Hospital, Minneapolis, Minnesota

Status

Recruiting

Address

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407

Site Contact

John Trusheim, MD

[email protected]

(833) 662-0044

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55414

Site Contact

Clark Chen, MD

[email protected]

(833) 662-0044

University of Nebraska, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska

Omaha, Nebraska, 68198

Site Contact

Michele Aizenberg, MD

[email protected]

402-559-6704

Englewood, New Jersey

Status

Not yet recruiting

Address

Clinical Research dep. Davison Place. Englewood Health

Englewood, New Jersey, 07631

Site Contact

Kevin Yao, MD

[email protected]

(833) 662-0044

Albany Medical Center, Albany, New York

Status

Recruiting

Address

Albany Medical Center

Albany, New York, 12208

Site Contact

Tuba Ahmed

[email protected]

518-262-5088

Mount Sinai Hospital, New York, New York

Status

Active, not recruiting

Address

Mount Sinai Hospital

New York, New York, 10029

SUNY Upstate Medical Center, Syracuse, New York

Status

Recruiting

Address

SUNY Upstate Medical Center

Syracuse, New York, 13210

Site Contact

Harish Babu, MD

[email protected]

315-464-4470

Westchester Medical Center, Valhalla, New York

Status

Recruiting

Address

Westchester Medical Center

Valhalla, New York, 10595

Site Contact

Simon Hanft

[email protected]

(833) 662-0044

University of North Carolina Health, Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina Health

Chapel Hill, North Carolina, 27599

Site Contact

Colette Shen, MD

[email protected]

(833) 662-0044

Vidant Heath - ECU Medical Center, Greenville, North Carolina

Status

Recruiting

Address

Vidant Heath - ECU Medical Center

Greenville, North Carolina, 27834

Site Contact

Stuart Lee, MD

[email protected]

252-847-1550

Mayfield Brain and Spine, Cincinnati, Ohio

Status

Recruiting

Address

Mayfield Brain and Spine

Cincinnati, Ohio, 45209

Site Contact

Vincent DiNapoli, MD

[email protected]

513-888-7564

Kettering Health, Kettering, Ohio

Status

Recruiting

Address

Kettering Health

Kettering, Ohio, 45429

Site Contact

Mark Hoeprich, MD

[email protected]

937-298-4331

Allentown, Pennsylvania

Status

Recruiting

Address

St Luke's University Health, Sacred Heart Campus

Allentown, Pennsylvania, 18102

Site Contact

Nimisha Deb, MD

[email protected]

484-503-4418

UT Southwestern Simmons Cancer Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Simmons Cancer Center

Dallas, Texas, 75235

Site Contact

Toral Patel, MD

[email protected]

(833) 662-0044

CHI Baylor St. Luke's Medical Center, Houston, Texas

Status

Recruiting

Address

CHI Baylor St. Luke's Medical Center

Houston, Texas, 77030

Site Contact

Akash Patel, MD

[email protected]

713-798-8810

Houston Methodist Hospital, Houston, Texas

Status

Recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030

Site Contact

David Baskin, MD

[email protected]

(833) 662-0044

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center of San Antonio

San Antonio, Texas, 78229

Site Contact

John Floyd, MD

[email protected]

(833) 662-0044

Texas Oncology-The Woodlands, The Woodlands, Texas

Status

Recruiting

Address

Texas Oncology-The Woodlands

The Woodlands, Texas, 77380

Site Contact

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

[email protected]

(833) 662-0044

Virginia Mason, Seattle, Washington

Status

Recruiting

Address

Virginia Mason

Seattle, Washington, 98101

Site Contact

Huong Pham, MD

[email protected]

206-287-6278

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