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

Recruiting

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

• Registration Number: NCT04427384
• Lead Sponsor: GT Medical Technologies, Inc.

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.

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-09-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2028-10-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (48)

HonorHeath Scottsdale Osborn Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas Medical Center; 🇺🇸 Little Rock, Arkansas, United States

Eden Medical Center; 🇺🇸 Castro Valley, California, United States

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

MemorialCare Health System; 🇺🇸 Laguna Hills, California, United States

Desert Regional Medical Center; 🇺🇸 Palm Springs, California, United States

California Pacific Medical Center, Sutter health; 🇺🇸 San Francisco, California, United States

Centura; 🇺🇸 Denver, Colorado, United States

Colorado Brain & Spine Institute: Swedish Campus; 🇺🇸 Englewood, Colorado, United States

BayCare Health; 🇺🇸 Clearwater, Florida, United States

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