New radiation tile could change brain metastasis treatment

NCT ID NCT04365374

Disease control Sponsor: GT Medical Technologies, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new radiation device called Gamma Tile, which is placed directly in the brain during surgery to deliver radiation immediately, versus standard radiation given weeks later. The study involves 230 adults with newly diagnosed brain metastases who need one tumor removed. The goal is to see if Gamma Tile improves tumor control and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Gamma Tile (a permanently implanted radiation device with cesium-131 seeds)
What this could lead to: If successful, this could offer a more convenient and potentially more effective radiation option for people with brain metastases, reducing the need for follow-up radiation sessions.
What could go wrong: This is a phase 3 trial, but results are not yet available. The Gamma Tile is a new device, and long-term safety or effectiveness compared to standard care is still unproven. Risks include infection, radiation side effects, or the device not improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged 18 years old and above. Eligibility is restricted to this age group given that the battery of neurocognitive tests utilized in this protocol are not developed or validated for use in a younger population. 2. One to six newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor. 3. Only one lesion, designated the index lesion, is planned for surgical resection. The index lesion must be between 2.0 and 7.0 cm in maximal extent on the screening MRI, and gross total resection is expected by the neurosurgeon. 4. Non-index lesions must measure ≤ 4.0 cm in maximal extent on the screening MRI brain scan. The unresected lesions will be treated with SRT as outlined in the treatment section of the concept. 5. All metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem. Dural based metastasis are eligible. 6. Previous and/or concurrent treatment with investigational or FDA approved systemic therapies (e.g., chemotherapy, targeted therapeutics, immunotherapy) are permitted and must follow protocol guidelines as follows: Systemic therapy is allowed a minimum of one week from last systemic therapy cycle to surgical resection, and one week after surgical resection to allow a minimum of one week before starting/resuming systemic therapy, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Systemic therapy is not allowed 1 day before SRT, the same day as the SRT, or 1 day after the completion of the SRT or longer, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Agents that are delivered by implant or depot injections (such as hormonal therapies) are excluded from these restrictions. 7. Karnofsky Performance Scale (KPS) score of ≥ 70. Patients with KPS \< 70 can be enrolled if their baseline KPS within 14 days of screening was estimated ≥ 70 and surgical management is expected to improve KPS to ≥ 70. 8. Stable systemic disease or reasonable systemic treatment options predicting a life expectancy of ≥6 months. 9. Ability to complete an MRI of the head with contrast 10. Adequate renal and hepatic function to undergo surgery, in investigators opinion. 11. For women of childbearing potential only, a negative urine or serum pregnancy test done \<7 days prior to randomization is required. Women must be willing to notify investigator immediately if they become pregnant at any time during the trial period. 12. Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment. 13. Subjects must be fluent in English, Spanish, or another language the study site is prepared to obtain informed consent for in this trial. English speaking subjects will complete Neurocognitive assessments. Non-English-speaking subjects are trial-eligible but will not complete the Neurocognitive assessments as the psychometric properties for translated tests are either not known or not as robust. 14. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves. Exclusion Criteria 1. Age \<18 years. 2. Karnofsky Performance Scale (KPS) score of \<70. Patients with KPS \< 70 can be enrolled if their baseline KPS within 14 days of screening was estimated ≥ 70 and surgical management is expected to improve KPS to ≥ 70. 3. Sensitivity to bovine (cow) derived materials including collagen products. 4. Past radiation or surgical therapy to the index lesion or the newly diagnosed non-index lesion(s) is exclusionary. However, up to a total of 2 prior courses of SRT treatment to previously diagnosed lesions are allowed as long as any treated lesions are were ≥15mm from the index lesion. 5. Patients with \>6 newly diagnosed metastases on screening MRI 6. Pregnant patients. 7. Primary germ cell tumor, small cell carcinoma, or lymphoma. 8. Leptomeningeal metastasis (LMD). Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as radiologic or clinical evidence of leptomeningeal involvement with or without positive cerebrospinal fluid (CSF) cytology. 9. Prior WBRT for brain metastases. 10. Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. 11. Comorbid psychiatric or neurologic disease or injury impacting cognition, in the opinion of the treating physician, that might impair patient's ability to understand or comply with the requirements of the study or to provide consent 12. 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.

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Conditions

The condition(s) this trial relates to.

brain cancer metastatic malignant neoplasm in the brain neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain metastases

Contacts and locations

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Advent health Orlando

Orlando, Florida, 32804, United States
Albany Medical Center

Albany, New York, 12208, United States
Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States
Ascension St. Vincent's- Riverside

Jacksonville, Florida, 32204, United States
Baptist MD Anderson Cancer Center- Jacksonville

Jacksonville, Florida, 32207, United States
Baylor St. Luke's Medical Center | Baylor College of Medicine

Houston, Texas, 77030, United States
Brown University Health

Providence, Rhode Island, 02906, United States
Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States
ECU Health

Greenville, North Carolina, 27834, United States
Ellis Fischel Cancer Center at University of Missouri

Columbia, Missouri, 65212, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

Tampa, Florida, 33606, United States
HCA Florida First Coast Neurology- Orange Park

Orange Park, Florida, 32073, United States
HMH Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
Henry Ford Health

Detroit, Michigan, 48202, United States
HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona, 85027, United States
Houston Methodist

Houston, Texas, 77030, United States
Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States
Mayfield Brain and Spine

Cincinnati, Ohio, 45209, United States
Memorial Sloan Kettering

New York, New York, 10065, United States
Orlando Health

Orlando, Florida, 32806, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
RUSH University

Chicago, Illinois, 60607, United States
SCRI with Texas Oncology

The Woodlands, Texas, 77380, United States
SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110, United States
The University Of Kansas Cancer Center

Kansas City, Kansas, 66016, United States
The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States
UT Health San Antonio

San Antonio, Texas, 78249, United States
UT Southwestern Simmons Cancer Center

Dallas, Texas, 75235, United States
University Of Minnesota

Minneapolis, Minnesota, 55414, United States
University of Arkansas Medical Center

Little Rock, Arkansas, 72205, United States
University of Louisville

Louisville, Kentucky, 40202, United States
University of North Carolina Health

Chapel Hill, North Carolina, 27599, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Virginia Mason

Seattle, Washington, 98101, United States
Westchester Medical Center

Westchester, New York, 10595, United States
Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

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