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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427384
• Other study ID #: GTM-101
• Status: Recruiting
• Start date: September 11, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: GT Medical Technologies, Inc.
• Contact: Michael A. Garcia, MD, MS
• Phone: (833) 662-0044
• Email: mgarcia[@]gtmedtech.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2028
• Est. primary completion date: October 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Device:
• GammaTile
Surgically Targeted Radiation Therapy

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	St Luke's University Health, Sacred Heart Campus	Allentown	Pennsylvania
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	St. Alphonsus Regional Medical Center	Boise	Idaho
United States	Eden Medical Center	Castro Valley	California
United States	University of North Carolina Health	Chapel Hill	North Carolina
United States	Mayfield Brain and Spine	Cincinnati	Ohio
United States	BayCare Health	Clearwater	Florida
United States	UT Southwestern Simmons Cancer Center	Dallas	Texas
United States	Centura	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Clinical Research dep. Davison Place. Englewood Health	Englewood	New Jersey
United States	Colorado Brain & Spine Institute: Swedish Campus	Englewood	Colorado
United States	Vidant Heath - ECU Medical Center	Greenville	North Carolina
United States	CHI Baylor St. Luke's Medical Center	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Indiana University, IU Health Methodist Hospital	Indianapolis	Indiana
United States	KUMC Dept of Neurosurgery	Kansas City	Kansas
United States	Kettering Health	Kettering	Ohio
United States	UCSD Moores Cancer Center	La Jolla	California
United States	University of Arkansas Medical Center	Little Rock	Arkansas
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Univeristy of Louisville Health	Louisville	Kentucky
United States	Miami Cancer Institute, Baptist Health South Florida	Miami	Florida
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mount Sinai Hospital	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Advent Health Orlando	Orlando	Florida
United States	Orlando Health	Orlando	Florida
United States	Desert Regional Medical Center	Palm Springs	California
United States	HonorHeath Scottsdale Osborn Medical Center	Phoenix	Arizona
United States	University of Texas Health Science Center of San Antonio	San Antonio	Texas
United States	California Pacific Medical Center, Sutter health	San Francisco	California
United States	Virginia Mason	Seattle	Washington
United States	Willis-Knighton Medical Center	Shreveport	Louisiana
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital	Tampa	Florida
United States	Texas Oncology-The Woodlands	The Woodlands	Texas
United States	Westchester Medical Center	Valhalla	New York
United States	Cleveland Clinic Florida- Weston	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GT Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects	No contrast enhancement in the area of the surgical bed	12 months
Primary	Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects	No contrast enhancement in the area of the surgical bed	3 years
Primary	Overall Survival in High Grade Glioma Subjects	Median duration of survival of subjects following surgical resection of tumor	9 months