This is a phase 2, open-label clinical trial determining feasibility, safety, and tolerability of GammaTile® in elderly or frail subjects with newly diagnosed or recurrent malignant gliomas.
Supratentorial
A bi-dimensionally measurable lesion of at least 10 mm, visible on two or more axial slices 5 mm apart.
The pre-operative tumor planned for resection is ≤ 7 cm in maximal dimension.
Tumor, which in the opinion of the enrolling neurosurgeon, is amenable to attempted gross total resection (GTR) or near total resection (NTR).
Staged surgery planned (prior biopsy allowed).
Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field.
Spinal tumors are excluded.
Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR or NTR.
Parallel
GammaTile®
DeviceGammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Percentage of Participants who were able to receive the GammaTile Implant
Feasibility is defined by proportion of participants who were able to be treated with GammaTile
Number of Participants with Treatment-related Adverse Events
Safety and tolerability will be determined by the proportion, nature, and severity of treatment-related adverse events in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) as measured by Response Assessment in Neuro-Oncology (RANO) 2.0 on brain MRI with and without contrast.
Overall Survival (OS)
Overall Survival (OS) as measured by time from registration to death of any cause as documented dates of registration and death within the electronic medical system.
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University of California, Irvine
Lead sponsor
GT Medical Technologies, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
