Home › Trials › NCT04427384

Registry of patients with brain tumors treated with GammaTiles

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

GT Medical Technologies, Inc. · NCT04427384

This study is testing how well GammaTiles treatment works for people with brain tumors after surgery, looking at their health and quality of life over five years.

Quick facts

Study typeObservational
Enrollment600 (estimated)
SexAll
SponsorGT Medical Technologies, Inc. (industry)
Drugs / interventionsradiation
Locations54 sites (Phoenix, Arizona and 53 other locations)
Trial IDNCT04427384 on ClinicalTrials.gov

What this trial studies

This registry study aims to evaluate the real-world clinical outcomes and patient-reported outcomes of patients with brain tumors who have undergone treatment with STaRT using GammaTiles. A total of 600 patients who have had maximum safe resection of their brain tumors will be enrolled, and data will be collected on various outcomes including local control, overall survival, quality of life, neurocognition, and adverse events over a period of five years. The study will benchmark the effectiveness and safety of this treatment approach against existing standard-of-care therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have undergone maximum safe resection of their brain tumors and are willing to participate in follow-up evaluations.

Not a fit: Patients with major medical or psychiatric illnesses that could interfere with treatment completion or follow-up assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of GammaTiles for treating brain tumors, potentially improving patient outcomes.

How similar studies have performed: This is the first observational registry study of R+STaRT using GammaTiles, making it a novel approach in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary, Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Adult Meningioma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.