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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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
GammaTile Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
  • Device: GammaTile
    Surgically Targeted Radiation Therapy

Recruiting Locations

HonorHealth Research Institute
Phoenix, Arizona 85027
Contact:
John Wanebo, MD

University of Arkansas Medical Center
Little Rock, Arkansas 72205
Contact:
Analiz Rodriguez, MD, PhD
501-296-1138

Eden Medical Center
Castro Valley, California 94546
Contact:
Lawrence Dickinson, MD
925-884-2360

UCSD Moores Cancer Center
La Jolla, California 92093
Contact:
David Piccioni, MD, PhD

Desert Regional Medical Center
Palm Springs, California 92262
Contact:
Amir Lavaf, MD
760-416-4770

California Pacific Medical Center, Sutter health
San Francisco, California 94109
Contact:
Lewis Leng, MD
415-600-0528

Colorado Brain & Spine Institute: Swedish Campus
Englewood, Colorado 80113
Contact:
Vadim Tsvankin, MD
303-783-8844

BayCare Health
Clearwater, Florida 33756
Contact:
Devon Haydon, MD

Miami Cancer Institute, Baptist Health South Florida
Miami, Florida 33176
Contact:
Rupesh Kotecha, MD

Orlando Health
Orlando, Florida 32806
Contact:
Catherine Mercado, MD

Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida 33606
Contact:
Tulika Ranjan, MD

Cleveland Clinic Florida- Weston
Weston, Florida 33331
Contact:
Surabhi Ranjan, MD, FACP
954-659-5670

Piedmont Healthcare
Atlanta, Georgia 30309
Contact:
Adam Nowlan, MD

Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
Contact:
Kimberly Bojanowski

St. Alphonsus Regional Medical Center
Boise, Idaho 83704
Contact:
Ondrej Choutka

Indiana University, IU Health Methodist Hospital
Indianapolis, Indiana 46202
Contact:
Mitesh Shah

KUMC Dept of Neurosurgery
Kansas City, Kansas 66160
Contact:
Kushal Shah

Univeristy of Louisville Health
Louisville, Kentucky 40202
Contact:
Akshitkumar Mistry, MD
502-588-2160

Norton Cancer Institute
Louisville, Kentucky 40241
Contact:
Parag Sevak, MD
Parag.Sevak@nortonhealthcare.org

Henry Ford Health System
Detroit, Michigan 48202
Contact:
Adam M Robin, MD

Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
John Trusheim, MD

University of Minnesota
Minneapolis, Minnesota 55414
Contact:
Clark Chen, MD

University of Nebraska
Omaha, Nebraska 68198
Contact:
Michele Aizenberg, MD
402-559-6704

Albany Medical Center
Albany, New York 12208
Contact:
Tuba Ahmed
518-262-5088

SUNY Upstate Medical Center
Syracuse, New York 13210
Contact:
Harish Babu, MD
315-464-4470

Westchester Medical Center
Valhalla, New York 10595
Contact:
Simon Hanft

University of North Carolina Health
Chapel Hill, North Carolina 27599
Contact:
Colette Shen, MD

Vidant
Greenville, North Carolina 27834
Contact:
Stuart Lee, MD
252-847-1550

Mayfield Brain and Spine
Cincinnati, Ohio 45209
Contact:
Vincent DiNapoli, MD
513-888-7564

Kettering Health
Kettering, Ohio 45429
Contact:
Mark Hoeprich, MD
937-298-4331

St Luke's University Health, Sacred Heart Campus
Allentown, Pennsylvania 18102
Contact:
Nimisha Deb, MD
484-503-4418
Nimisha.Deb@sluhn.org

UT Southwestern Simmons Cancer Center
Dallas, Texas 75235
Contact:
Toral Patel, MD

Baylor St. Luke's Medical Center
Houston, Texas 77030
Contact:
Akash Patel, MD
713-798-8810

The Methodist Hospital Research Institute
Houston, Texas 77030
Contact:
David Baskin, MD

University of Texas Health Science Center of San Antonio
San Antonio, Texas 78229
Contact:
John Floyd, MD

Texas Oncology-The Woodlands
The Woodlands, Texas 77380
Contact:
James Zhu, M.D., Ph.D.
james.zhu@usoncology.com

Virginia Mason
Seattle, Washington 98101
Contact:
Huong Pham, MD
206-287-6278

More Details

NCT ID
NCT04427384
Status
Recruiting
Sponsor
GT Medical Technologies, Inc.

Study Contact

Michael A. Garcia, MD, MS
(833) 662-0044
mgarcia@gtmedtech.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.