RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Quick Facts

Study Start:2020-09-11
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04427384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
  2. 2. Willing and able to provide informed consent and to participate in all evaluations.
  1. 1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
  2. 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. 3. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).

Contacts and Locations

Study Contact

Michael A. Garcia, MD, MS
CONTACT
(833) 662-0044
mgarcia@gtmedtech.com
Sita Patel, PhD, PharmD
CONTACT
(833)662-0044
spatel@gtmedtech.com

Principal Investigator

Michael A. Garcia, MD, MS
STUDY_DIRECTOR
GT Medical Technologies

Study Locations (Sites)

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
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
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
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
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
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
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
CHI Baylor St. Luke's Medical Center
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

Collaborators and Investigators

Sponsor: GT Medical Technologies, Inc.

  • Michael A. Garcia, MD, MS, STUDY_DIRECTOR, GT Medical Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-11
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2020-09-11
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

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