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

March 12, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • HonorHealth Research Institute
        • 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
      • 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
      • 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
      • 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
      • 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
    • 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:
          • Clark Chen, MD
      • 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
      • 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
      • 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
        • Contact:
          • Stuart Lee, MD
          • Phone Number: 252-847-1550
    • 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
        • Contact:
        • Principal Investigator:
          • Nimisha Deb, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern Simmons Cancer Center
        • Contact:
          • Toral Patel, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor St. Luke's Medical Center
        • Contact:
          • Akash Patel, MD
          • Phone Number: 713-798-8810
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital Research Institute
        • Contact:
          • David Baskin, MD
      • 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
    • 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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received STaRT 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. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).

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
Intervention / Treatment
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

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

GT Medical Technologies, Inc.

Investigators

  • 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)

September 11, 2020

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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