Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
Study NCT ID:
NCT05303467
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2022-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRONTIER
Brief Summary:
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.
Detailed Description:
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 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: