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

February 11, 2026 updated by: GT Medical Technologies, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • HonorHeath Scottsdale Osborn Medical Center
        • Contact:
          • John Wanebo, MD
        • Principal Investigator:
          • John Wanebo, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas Medical Center
        • Contact:
          • Analiz Rodriguez, MD, PhD
          • Phone Number: 501-296-1138
    • California
      • Castro Valley, California, United States, 94546
        • Recruiting
        • Eden Medical Center
        • Contact:
          • Lawrence Dickinson, MD
          • Phone Number: 925-884-2360
        • Principal Investigator:
          • Lawrence Dickinson, MD
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD Moores Cancer Center
        • Principal Investigator:
          • David Piccioni, MD, PhD
        • Contact:
          • David Piccioni, MD, PhD
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • MemorialCare Health System
        • Principal Investigator:
          • Linda Chan, MD
        • Contact:
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Desert Regional Medical Center
        • Contact:
          • Amir Lavaf, MD
          • Phone Number: 760-416-4770
        • Principal Investigator:
          • Amir Lavaf, MD
      • San Francisco, California, United States, 94109
        • Recruiting
        • California Pacific Medical Center, Sutter health
        • Contact:
          • Lewis Leng, MD
          • Phone Number: 415-600-0528
        • Principal Investigator:
          • Lewis Leng, MD
    • Colorado
      • Denver, Colorado, United States, 80201
        • Not yet recruiting
        • Centura
        • Contact:
          • Angela Bohnen, MD
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Colorado Brain & Spine Institute: Swedish Campus
        • Contact:
          • Vadim Tsvankin, MD
          • Phone Number: 303-783-8844
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • BayCare Health
        • Contact:
          • Devon Haydon, MD
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Ascension St. Vincent's
        • Principal Investigator:
          • Aristotelis Filippidis, MD
        • Contact:
          • Amanda Lindewood
          • Phone Number: 904-308-5761
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute, Baptist Health South Florida
        • Contact:
          • Rupesh Kotecha, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
        • Contact:
          • Catherine Mercado, MD
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Advent Health Orlando
        • Principal Investigator:
          • Imran Mohiuddin, MD
        • Contact:
          • Imran Mohiuddin, MD
          • Phone Number: 407-303-2030
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
        • Contact:
          • Tulika Ranjan, MD
        • Contact:
          • Phone Number: 813-844-7585
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida- Weston
        • Contact:
          • Surabhi Ranjan, MD, FACP
          • Phone Number: 954-659-5670
        • Principal Investigator:
          • Surabhi Ranjan, MD, FACP
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Contact:
          • Kimberly Bojanowski
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare
        • Contact:
          • Adam Nowlan, MD
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • St. Alphonsus Regional Medical Center
        • Contact:
          • Ondrej Choutka
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Goodman Campbell Brain and Spine
        • Principal Investigator:
          • Kushal Shah, MD
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University, IU Health Methodist Hospital
        • Contact:
          • Mitesh Shah
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • KUMC Dept of Neurosurgery
        • Contact:
          • Kushal Shah
    • Kentucky
      • Louisville, Kentucky, United States, 40241
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Univeristy of Louisville Health
        • Contact:
          • Akshitkumar Mistry, MD
          • Phone Number: 502-588-2160
        • Principal Investigator:
          • Akshitkumar Mistry, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Withdrawn
        • Willis-Knighton Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Rafael Vega, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
          • Adam M Robin, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Contact:
          • Lindsey Sloan, MD, PhD
        • Principal Investigator:
          • Lindsey Sloan, MD, PhD
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
          • John Trusheim, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska
        • Contact:
          • Michele Aizenberg, MD
          • Phone Number: 402-559-6704
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Not yet recruiting
        • Clinical Research dep. Davison Place. Englewood Health
        • Contact:
          • Kevin Yao, MD
        • Contact:
          • Dubin David, MD
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Principal Investigator:
          • Alexandra Paul, MD
        • Contact:
          • Tuba Ahmed
          • Phone Number: 518-262-5088
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Mount Sinai Hospital
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical Center
        • Contact:
          • Harish Babu, MD
          • Phone Number: 315-464-4470
        • Principal Investigator:
          • Harish Babu, MD
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Einstein
        • Contact:
          • Genesis Liriano
          • Phone Number: 718-920-4321
        • Principal Investigator:
          • Vijay Agarwal, MD
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
          • Simon Hanft
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina Health
        • Contact:
          • Colette Shen, MD
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Vidant Heath - ECU Medical Center
        • Contact:
          • Stuart Lee, MD
          • Phone Number: 252-847-1550
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Recruiting
        • Mayfield Brain and Spine
        • Contact:
          • Vincent DiNapoli, MD
          • Phone Number: 513-888-7564
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Health
        • Principal Investigator:
          • Mark Hoeprich, MD
        • Contact:
          • Mark Hoeprich, MD
          • Phone Number: 937-298-4331
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Recruiting
        • St Luke's University Health, Sacred Heart Campus
        • Principal Investigator:
          • William Smith, MD
        • Contact:
          • William Smith, MD
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health
        • Contact:
          • Rachel Horstman
        • Principal Investigator:
          • Sean Mahase, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
        • Principal Investigator:
          • Matthew Shepard, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Brown University Health
        • Contact:
        • Principal Investigator:
          • Clark Chen, MD, PhD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern Simmons Cancer Center
        • Contact:
          • Toral Patel, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • David Baskin, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor St. Luke's Medical Center | Baylor College of Medicine
        • Contact:
          • Akash Patel, MD
          • Phone Number: 713-798-8810
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center of San Antonio
        • Contact:
          • John Floyd, MD
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology-The Woodlands
        • Contact:
        • Principal Investigator:
          • James Zhu, M.D., Ph.D
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • INOVA Health
        • Principal Investigator:
          • Daniel Kim, MD
        • Contact:
          • Daniel Kim, MD
          • Phone Number: 571-472-0606
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason
        • Principal Investigator:
          • Huong Pham, MD
        • Contact:
          • Huong Pham, MD
          • Phone Number: 206-287-6278
        • Principal Investigator:
          • Roby Ryan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received STaRT (GammaTile) intraoperatively.

Description

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. 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

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
GammaTile
Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
Device: GammaTile
Surgically Targeted Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
Time Frame: 12 months
No contrast enhancement in the area of the surgical bed
12 months
Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
Time Frame: 3 years
No contrast enhancement in the area of the surgical bed
3 years
Overall Survival in High Grade Glioma Subjects
Time Frame: 9 months
Median duration of survival of subjects following surgical resection of tumor
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GT Medical Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael A. Garcia, MD, MS, GT Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GTM-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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