Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Single treatment of TheraSphere GBM device

TheraSphere GBM

Sally Linda

Franco Basarabescu

Stephanie Lewis

Nicholas Butowski, MD

Ewa Szymkiewicz

Alfredo Quinones-Hinojosa, MD

Roger Stupp, MD

Emily R Powell

Samdeep Mouli, MD

Hannatu Bwayili

Sasicha Manupipatpong

Clifford Weiss, MD

Tamika Wong

John Boockvar, MD

The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.

Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in \<7% of patients surviving to five years post-diagnosis. External beam radiotherapy (EBRT) is currently a mainstay treatment for GBM; however, the dose delivered is limited by side effects. The targeted radiotherapy of the TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) has promising potential to provide GBM patients with reduced side effects compared to external beam radiotherapy as well as a more effective treatment for this catastrophic disease.

The TheraSphere GBM device utilized in the FRONTIER trial is an yttrium-90 (Y-90) glass microsphere therapy for selective internal radiation therapy (endovascular radiotherapy) in recurrent GBM patients. The TheraSphere GBM treatment utilizes intra-arterial delivery and takes advantage of blood flow and direct tumor delivery. Treatment can be delivered by specific placement of a catheter close to the tumor through known angiographic techniques currently utilized by neuro-endovascular or interventional radiology physicians. Angiographic evaluation prior to treatment allows identification of tumor feeding arteries and definition of the treatment volume. TheraSphere GBM could achieve a high tumor response rate based on delivery of a tumor absorbed dose that is not currently possible with EBRT.

In consideration of the potential benefit of a more localized, targeted treatment with a reduced side effect profile compared to other treatment options, and the potential impact on patients' quality of life for this devastating disease, this First-in-Human Early Feasibility Study (EFS) of the TheraSphere GBM Y-90 Glass Microsphere System for the treatment of recurrent GBM is being conducted.

The TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) is an yttrium-90 (Y-90) glass microsphere therapy for selective internal radiation therapy (endovascular radiotherapy) in recurrent GBM patients

A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM

FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM

The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.

The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability on a scale from 0 (no symptoms at all) to 6 (death).

Boston Scientific Corporation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM	NCT05303467	Glioblastoma Mu... Recurrent Gliob...	TheraSphere GBM	18 Years -	Boston Scientific Corporation
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM	NCT05303467	Glioblastoma Mu... Recurrent Gliob...	TheraSphere GBM	18 Years -	Boston Scientific Corporation
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM	NCT05303467	Glioblastoma Mu... Recurrent Gliob...	TheraSphere GBM	18 Years -	Boston Scientific Corporation

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