GammaTile for Brain Cancer

Recruiting at 59 trial locations

Overseen By Sita Patel, PhD, PharmD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: GT Medical Technologies, Inc.

Disqualifiers: Major illness, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well GammaTile works for people with brain tumors. GammaTile, a type of radiation therapy, is implanted directly into the brain immediately after tumor surgery. The trial aims to assess the safety and effectiveness of this treatment in real-world use. Individuals who have undergone surgery to remove a brain tumor and received GammaTile implants might be suitable candidates for this trial. Participants should be prepared to engage in all study evaluations and follow-ups.

As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the validation of a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that GammaTile is safe for patients with brain tumors?

Studies have shown that GammaTile, a treatment for brain tumors, is generally safe. Research indicates that most patients tolerate the treatment well, with only 3.6% experiencing serious side effects within 90 days. Severe side effects are thus rare shortly after the procedure. Additionally, the FDA has approved GammaTile, confirming it has passed safety checks for treating brain tumors. It has been used in over 1,500 procedures, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

GammaTile is unique because it provides targeted radiation therapy directly to the site of a brain tumor immediately after surgical removal. Unlike traditional radiation treatments, which require multiple visits and affect surrounding healthy tissue, GammaTile delivers radiation precisely where it's needed, potentially reducing side effects and enhancing recovery. Researchers are excited about GammaTile's ability to offer immediate and localized treatment, which may improve outcomes and quality of life for brain tumor patients.

What evidence suggests that GammaTile is effective for brain tumors?

Research has shown that GammaTile, the treatment under study in this trial, effectively treats brain tumors. Studies have found that it controls tumors better than standard treatments, particularly in newly diagnosed cases. For recurrent brain tumors, GammaTile achieved an impressive one-year local control rate of 80%. Patients who received GammaTile experienced over a 50% lower risk of tumor recurrence or death compared to those who received standard treatments. These findings suggest that GammaTile can significantly aid in managing brain tumors and improving patient outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Michael A. Garcia, MD, MS

Principal Investigator

GT Medical Technologies

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive GammaTile radiation therapy immediately following brain tumor resection

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 1, 3, 6, 9, 12, 18, and 24 months, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• GammaTile

How Is the Trial Designed?

Group I: GammaTile Experimental Treatment 1 Intervention

Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.

Who Is Running the Clinical Trial?

GT Medical Technologies, Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

Citations

1. gammatile.com gammatile.com/hcp/clinical-evidence/

Clinical Evidence: Healthcare Providers Evidence with impact. Clinical studies show GammaTile consistently delivers outcomes that matter for patients with operable brain tumors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10834587/

The role of GammaTile in the treatment of brain tumors The estimated 1-year LC of recurrent previously irradiated brain metastases treated with GammaTile was 80%. The single patient that experienced ...

3. prnewswire.com prnewswire.com/news-releases/journal-of-neuro-oncology-publishes-new-data-reinforcing-gammatile-efficacy-in-treating-recurrent-brain-metastases-302553545.html

Journal of Neuro-Oncology Publishes New Data ... Breakthrough clinical trial confirms that GammaTile delivers superior tumor control compared to standard of care for patients with newly ...

4. gammatile.com gammatile.com/hcp/

GammaTile: Healthcare Providers GammaTile treatment for newly diagnosed brain tumors is a significant step forward for patients and an example of the benefits that focused neurosurgical ...

5. curetoday.com curetoday.com/view/gammatile-may-reduce-risk-of-brain-tumor-recurrence-or-death

GammaTile May Reduce Risk of Brain Tumor Recurrence ... GammaTile treatment reduces tumor recurrence or death risk by over 50% compared to standard care in operable brain metastases. More than half of ...

6. gammatile.com gammatile.com/

GammaTile Radiation Therapy FDA-cleared, bioresorbable collagen tile embedded with radiation sources that safely and precisely target any remaining cancer cells. · Immediate: No radiation ...

7. gammatile.com gammatile.com/gammatile/faq/

GammaTile Frequently Asked Questions Is GammaTile brain tumor treatment safe? Yes. GammaTile is FDA-cleared, has been used in over 1,500 procedures and is supported by ongoing research through ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11487344/

Early experience and perioperative risk of GammaTile for ... GT demonstrates a favorable safety profile in upfront brain metastases with a 3.6% rate of serious AEs (grade ≥ 3) within 90 days of the procedure.

9. rush.edu rush.edu/gammatile-therapy-rush

GammaTile Therapy at Rush GammaTile (GT) therapy is a new, FDA-cleared technology that provides intracranial delivery of radiation to patients who have had their operable brain tumor ...