Recruiting

GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Brain Neoplasms: Assessment of Clinical Outcomes and Quality of Life

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Study Aim

This study aims to observe the overall survival in high grade glioma patients and the surgical bed-recurrence free survival in meningioma and metastatic tumor patients following surgical resection and treatment with GammaTile™ Surgically Targeted Radiation Therapy.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+10

+ Brain Neoplasms

+ Central Nervous System Diseases

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2020
See protocol details

Summary

Principal SponsorGT Medical Technologies, Inc.
Study ContactMichael A. Garcia, MD, MSMore contacts
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2020

Actual date on which the first participant was enrolled.

This study focuses on a treatment called GammaTile™ Surgically Targeted Radiation Therapy (STaRT) for individuals who have had brain tumors of any type surgically removed. The research aims to gather data from 600 participants to understand the effectiveness and safety of this treatment in a real-world setting. It's important because it could provide a new benchmark for comparing STaRT therapy with current standard treatments, potentially improving care for those with brain tumors. Participants in this observational study will have their progress tracked at regular intervals - 1, 3, 6, 9, 12, 18, and 24 months, then every 6 months until 5 years. The study will measure overall survival for those with high-grade glioma, and recurrence-free survival for those with meningioma and metastatic tumors. It will also assess quality of life, cognitive function, functional decline, and any side effects related to surgery or radiation. The results will help evaluate the potential risks and benefits of this treatment approach.

Official TitleA Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
NCT04427384
Principal SponsorGT Medical Technologies, Inc.
Study ContactMichael A. Garcia, MD, MSMore contacts
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsCentral Nervous System DiseasesMeningeal NeoplasmsMeningiomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Nerve TissueNeoplasms, Vascular TissueNervous System DiseasesNervous System NeoplasmsCentral Nervous System Neoplasms

Criteria

2 inclusion criteria required to participate
Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Willing and able to provide informed consent and to participate in all evaluations.
3 exclusion criteria prevent from participating
Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
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.
Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 54 locations

Recruiting

HonorHeath Scottsdale Osborn Medical Center

Phoenix, United StatesOpen HonorHeath Scottsdale Osborn Medical Center in Google Maps
Recruiting

University of Arkansas Medical Center

Little Rock, United States
Recruiting

Eden Medical Center

Castro Valley, United States
Recruiting

UCSD Moores Cancer Center

La Jolla, United States
Recruiting
54 Study Centers