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Brain Tumor, RecurrentNCT04427384

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

An observational study of Brain Tumor, Recurrent and Brain Tumor, run by GT Medical Technologies, Inc. at 54 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
GammaTile
Type of treatment
Medical device
How many people
600 participants
Where
54 sitesUnited States
Study dates
11 Sep 2020to 31 Dec 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who received STaRT (GammaTile) intraoperatively.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

54 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael A. Garcia, MD, MS contact

(833) 662-0044

mgarcia@gtmedtech.com

Sita Patel, PhD, PharmD contact

(833)662-0044

spatel@gtmedtech.com

54 sites in 1 country

United States54 sites, 51 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Tuba Ahmed, 518-262-5088

    Alexandra Paul, MD

    Recruiting

  • St Luke's University Health, Sacred Heart Campus

    Allentown, Pennsylvania, 18102

    William Smith, MD

    William Smith, MD

    Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

    Adam Nowlan, MD

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Kimberly Bojanowski

    Recruiting

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83704

    Ondrej Choutka

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Stephen Duggan

    Rafael Vega, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Rafael Vega, MD, rvega@bidmc.harvard.edu

    Rafael Vega, MD

    Recruiting

  • Goodman Campbell Brain and Spine

    Carmel, Indiana, 46032

    Heather Cero, 317-396-1448, hcero@goodmancampbell.com

    Kushal Shah, MD

    Recruiting

  • Eden Medical Center

    Castro Valley, California, 94546

    Lawrence Dickinson, MD, 925-884-2360

    Lawrence Dickinson, MD

    Recruiting

  • University of North Carolina Health

    Chapel Hill, North Carolina, 27599

    Active, not recruiting

  • CHI Memorial Hospital, CommonSpirit

    Chattanooga, Tennessee, 37404

    Ginger Whisman, ginger.whisman@commonspirit.org

    Ranjith Babu, MD

    Recruiting

  • Mayfield Brain and Spine

    Cincinnati, Ohio, 45209

    Vincent DiNapoli, MD, 513-888-7564

    Recruiting

  • BayCare Health

    Clearwater, Florida, 33756

    Devon Haydon, MD

    Recruiting

  • UT Southwestern Simmons Cancer Center

    Dallas, Texas, 75235

    Toral Patel, MD

    Recruiting

  • Centura

    Denver, Colorado, 80201

    Angela Bohnen, MD

    Not yet recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Adam M Robin, MD

    Recruiting

  • Colorado Brain & Spine Institute: Swedish Campus

    Englewood, Colorado, 80113

    Vadim Tsvankin, MD, 303-783-8844

    Recruiting

  • Clinical Research dep. Davison Place. Englewood Health

    Englewood, New Jersey, 07631

    Kevin Yao, MD

    Dubin David, MD

    Not yet recruiting

  • INOVA Health

    Fairfax, Virginia, 22031

    Daniel Kim, MD, 571-472-0606

    Daniel Kim, MD

    Recruiting

  • Vidant Heath - ECU Medical Center

    Greenville, North Carolina, 27834

    Stuart Lee, MD, 252-847-1550

    Recruiting

  • Penn State Health

    Hershey, Pennsylvania, 17033

    Rachel Horstman

    Sean Mahase, MD

    Recruiting

  • Baylor St. Luke's Medical Center | Baylor College of Medicine

    Houston, Texas, 77030

    Akash Patel, MD, 713-798-8810

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    David Baskin, MD

    Recruiting

  • Indiana University, IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

    Mitesh Shah

    Recruiting

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204

    Amanda Lindewood, 904-308-5761

    Aristotelis Filippidis, MD

    Recruiting

  • KUMC Dept of Neurosurgery

    Kansas City, Kansas, 66160

    Kushal Shah

    Recruiting

  • Kettering Health

    Kettering, Ohio, 45429

    Mark Hoeprich, MD, 937-298-4331

    Mark Hoeprich, MD

    Recruiting

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

    David Piccioni, MD, PhD

    David Piccioni, MD, PhD

    Recruiting

  • MemorialCare Health System

    Laguna Hills, California, 92653

    Linda Chan, MD, 562-933-0900, lchan@memorialcare.org

    Linda Chan, MD

    Recruiting

  • University of Arkansas Medical Center

    Little Rock, Arkansas, 72205

    Analiz Rodriguez, MD, PhD, 501-296-1138

    Recruiting

  • Univeristy of Louisville Health

    Louisville, Kentucky, 40202

    Akshitkumar Mistry, MD, 502-588-2160

    Akshitkumar Mistry, MD

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

    Parag Sevak, MD, Parag.Sevak@nortonhealthcare.org

    Parag Sevak, MD

    Recruiting

  • Miami Cancer Institute, Baptist Health South Florida

    Miami, Florida, 33176

    Rupesh Kotecha, MD

    Recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    John Trusheim, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Lindsey Sloan, MD, PhD

    Lindsey Sloan, MD, PhD

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Active, not recruiting

  • University of Nebraska

    Omaha, Nebraska, 68198

    Michele Aizenberg, MD, 402-559-6704

    Recruiting

  • Advent Health Orlando

    Orlando, Florida, 32803

    Imran Mohiuddin, MD, 407-303-2030

    Imran Mohiuddin, MD

    Recruiting

  • Orlando Health

    Orlando, Florida, 32806

    Catherine Mercado, MD

    Recruiting

  • Desert Regional Medical Center

    Palm Springs, California, 92262

    Amir Lavaf, MD, 760-416-4770

    Amir Lavaf, MD

    Recruiting

  • HonorHeath Scottsdale Osborn Medical Center

    Phoenix, Arizona, 85027

    John Wanebo, MD

    John Wanebo, MD

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

    Sarah Kimutis, 412-359-3565, sarah.kimutis@ahn.org

    Matthew Shepard, MD

    Recruiting

  • Brown University Health

    Providence, Rhode Island, 02906

    Clarck Chen, MD, PhD, 401-793-9166, clark.chen@lifespan.org

    Clark Chen, MD, PhD

    Recruiting

  • University of Texas Health Science Center of San Antonio

    San Antonio, Texas, 78229

    John Floyd, MD

    Recruiting

  • California Pacific Medical Center, Sutter health

    San Francisco, California, 94109

    Lewis Leng, MD, 415-600-0528

    Lewis Leng, MD

    Recruiting

  • Virginia Mason

    Seattle, Washington, 98101

    Huong Pham, MD, 206-287-6278

    Huong Pham, MD

    Recruiting

  • Willis-Knighton Medical Center

    Shreveport, Louisiana, 71103

    Withdrawn

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

    Harish Babu, MD, 315-464-4470

    Harish Babu, MD

    Recruiting

  • Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

    Tampa, Florida, 33606

    Tulika Ranjan, MD

    813-844-7585

    Recruiting

  • Montefiore Einstein

    The Bronx, New York, 10467

    Genesis Liriano, 718-920-4321

    Vijay Agarwal, MD

    Recruiting

  • Texas Oncology-The Woodlands

    The Woodlands, Texas, 77380

    James Zhu, M.D., Ph.D., james.zhu@usoncology.com

    James Zhu, M.D., Ph.D

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Simon Hanft

    Recruiting

  • Cleveland Clinic Florida- Weston

    Weston, Florida, 33331

    Surabhi Ranjan, MD, FACP, 954-659-5670

    Surabhi Ranjan, MD, FACP

    Recruiting

  • Atlantic Brain & Spine

    Wilmington, North Carolina, 28401

    Bridgette Smith, b.smith@atlanticbrainandspine.com

    Jeffrey Beecher, DO

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
GammaTile
Medical subject headings
Brain Neoplasms, Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GammaTileDevice

    Surgically Targeted Radiation Therapy

Study groups in NCT04427384
Study groupRoleWhat they receive
GammaTilePatients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
Receives: Device: GammaTile

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects

    No contrast enhancement in the area of the surgical bed

    Measured: 12 months

  2. Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects

    No contrast enhancement in the area of the surgical bed

    Measured: 3 years

  3. Overall Survival in High Grade Glioma Subjects

    Median duration of survival of subjects following surgical resection of tumor

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start11 Sep 2020
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04427384
Sponsor's protocol ID
GTM-101
Status last verified
Jul 2026
First submitted
5 Jun 2020
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Tumor, Recurrent and Brain Tumor, run by GT Medical Technologies, Inc. at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael A. Garcia, MD, MS ((833) 662-0044, mgarcia@gtmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04427384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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