Clinical trial NCT04427384: Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
Official title: A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor, Recurrent
Brain Tumor
Brain Tumor, Primary
Brain Tumor - Metastatic
Brain Tumor, Adult: Glioblastoma
Brain Tumor, Adult Meningioma
Lead sponsor: GT Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received STaRT intraoperatively.

Brief 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: 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).

Primary outcomes:
measure: Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
timeFrame: 12 months
measure: Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
timeFrame: 3 years
measure: Overall Survival in High Grade Glioma Subjects
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHeath Scottsdale Osborn Medical Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas Medical Center
state: Arkansas
city: Castro Valley
country: United States
facility: Eden Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Laguna Hills
country: United States
facility: MemorialCare Health System
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center, Sutter health
state: California
city: Denver
country: United States
facility: Centura
state: Colorado
city: Englewood
country: United States
facility: Colorado Brain & Spine Institute: Swedish Campus
state: Colorado
city: Clearwater
country: United States
facility: BayCare Health
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute, Baptist Health South Florida
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Tampa
country: United States
facility: Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida- Weston
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Indianapolis
country: United States
facility: Indiana University, IU Health Methodist Hospital
state: Indiana
city: Kansas City
country: United States
facility: KUMC Dept of Neurosurgery
state: Kansas
city: Louisville
country: United States
facility: Univeristy of Louisville Health
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Shreveport
country: United States
facility: Willis-Knighton Medical Center
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Englewood
country: United States
facility: Clinical Research dep. Davison Place. Englewood Health
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Health
state: North Carolina
city: Greenville
country: United States
facility: Vidant Heath - ECU Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Brain & Spine
state: North Carolina
city: Cincinnati
country: United States
facility: Mayfield Brain and Spine
state: Ohio
city: Kettering
country: United States
facility: Kettering Health
state: Ohio
city: Allentown
country: United States
facility: St Luke's University Health, Sacred Heart Campus
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Providence
country: United States
facility: Brown University Health
state: Rhode Island
city: Chattanooga
country: United States
facility: CHI Memorial Hospital, CommonSpirit
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Simmons Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center | Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center of San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology-The Woodlands
state: Texas
city: Fairfax
country: United States
facility: INOVA Health
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
Study officials:
affiliation: GT Medical Technologies
name: Michael A. Garcia, MD, MS
role: STUDY_DIRECTOR
References: