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

Study acronym: FRONTIER
StatusRecruiting
PhasePhase 1
Started2022-07-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Oct 31, 2026 → Jan 31, 2027
See other at-risk trials from Boston Scientific Corporation

Amendment history

The 50 most recent of 52 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-29
Primary completion pushed: 2026-10-31 → 2027-01-31
Completion pushed: 2027-04-30 → 2027-06-30
2026-08-25
Study Status, Contacts/Locations v51
Study sitesdetails revised at 1 of 9 sites
2026-07-30
Study Status v50
Re-verified, no change to tracked fields
2026-06-22
Study Status v49
Primary completion pushed: 2026-07-31 → 2026-10-31
Completion pushed: 2027-01-31 → 2027-04-30
2026-05-29
3 amendments v46-v48
3 re-verifications since 2026-03-24, no change to tracked fields
Show 44 earlier versions
2026-02-26
Study Status, Contacts/Locations v45
Study sitesdetails revised at 1 of 9 sites
2026-01-28
Study Status, Contacts/Locations v44
Primary completion date2026-03-31→2026-07-31
Completion date2026-06-01→2027-01-31
Study sitesdetails revised at 1 of 9 sites
2025-12-19
3 amendments v41-v43
3 re-verifications since 2025-10-22, no change to tracked fields
2025-09-26
Study Status, Contacts/Locations v40
Study sites7→9
2025-08-06
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 7 sites
2025-07-21
Study Status, Contacts/Locations v38
Study sites6→7
2025-06-25
Study Status, Contacts/Locations v37
Study sites5→6
2025-05-09
Study Status, Contacts/Locations v36
Study sitesdetails revised at 1 of 5 sites
2025-04-30
Active, Not Recruiting→Recruiting Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v35
Trial statusActive, Not Recruiting→Recruiting
PhaseEarly Phase 1→Phase 1
Primary completion date2024-12-04→2026-03-31
Completion date2025-06-01→2026-06-01
Enrollment target12→36
Study arms1→4
Eligibility criteria+191 characters
[...] ial radiation must be at least 12 weeks Interval since last cytotoxicsystemic therapy until presumed date of intervention ≥ 1 cycle or ≥ [...] ule targeted agent (Tyrosine Kinase Inhibitor or similar) ≥ 126 weeks from last dose of last intravenous bevacizumab infusi [...] eraSphere GBM to treat all of the T1 enhancing component of target lesion confirmed by neuro-interventional team. Total treatment volume is ≤ 150cc inas determined by multidisciplinary team. Additional Inclusion Criteria: Group A: perfused volume encompasses the non-dominant hemisphere and non-eloquent regions asof determinedthe bybrain G [...] [...]
Secondary endpoints7 entries, revised
Technical Success/Feasibility of TheraSphere GBM- - ability to deliver the targetprojected radiation absorbed dose (+/- 20%) to the perfused volume for all pati [...]
Study sitesdetails revised at 5 of 5 sites
2025-03-27
3 amendments v32-v34
3 re-verifications since 2025-01-27, no change to tracked fields
2024-12-23
Study Identification, Study Status, Oversight v31
Primary completion dateestimated 2024-12-01→confirmed 2024-12-04
Study titlerevised
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients withWith Recurrent GBM
2024-11-26
Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Study Design, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 5 of 5 sites
Study titlerevised
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients Withwith Recurrent GBM
2024-10-25
5 amendments v25-v29
5 re-verifications since 2024-06-26, no change to tracked fields
2024-05-24
Study Status, Contacts/Locations v24
Study sitescontacts updated at 1 of 5 sites
2024-04-10
Study Status v23
Primary completion date2024-06-01→2024-12-01
2024-03-05
Study Status, Contacts/Locations v22
Study sitescontacts updated at 1 of 5 sites
2024-02-14
Study Status, Eligibility v21
Eligibility criteria+1 characters
[...] 00/L Creatinine ≤1.5 mg/dL Absolute Neutrophil Count ≥1.5 x 10910^9/L Hemoglobin ≥9.0 g/dL Have a negative pregnancy test withi [...]
2024-01-09
Study Status, Eligibility, Contacts/Locations v20
Eligibility criteria+112 characters
[...] ≥ 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase Inhibitor or similar) ≥ 12 weeks from last dose of last intravenous bevacizumab infusion, Tyrosine Kinase Inhibitor, or other antiantibody-based VEGFRVEGF therapy If receiving steroids, patient should be on a stabl [...] cular anatomy that allows for safe microcatheter placement (singleup locationto two locations) to infuse TheraSphere GBM to treat all of the T1 enhancing [...] component of lesion confirmed by neuro-interventional team. TreatmentTotal treatment volume is ≤ 150cc in the non-dominant hemisphere and non-el [...] etastatic d [...]
Study sitescontacts updated at 1 of 5 sites
2023-12-12
Study Status v19
Primary completion date2024-01-01→2024-06-01
Completion date2024-06-01→2025-06-01
2023-11-17
Study Status v18
Re-verified, no change to tracked fields
2023-10-04
Study Status, Eligibility v17
Eligibility criteria+407 characters
[...] currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team) Angiographic Mapping Exclusion Criteria: Patients with significant vascular disease, significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precl [...]
2023-09-19
2 amendments v15-v16
2 re-verifications since 2023-08-29, no change to tracked fields
2023-07-13
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 5 sites
2023-06-21
3 amendments v11-v13
3 re-verifications since 2023-04-12, no change to tracked fields
2023-03-09
Study Status, Contacts/Locations v10
Primary completion date2023-04-01→2024-01-01
Completion date2024-04-01→2024-06-01
Study sitesdetails revised at 2 of 5 sites
2023-02-13
4 amendments v6-v9
4 re-verifications since 2022-11-08, no change to tracked fields
2022-10-17
Study Status, Study Description, Contacts/Locations v5
Study description-21 characters
[...] ing to five years post-diagnosis. External beam radiotherapy (EBRT) is currently a mainstay treatment for GBM; however, the dos [...] herapy (endovascular radiotherapy) in recurrent GBM patients as a neoadjuvant to surgery. The TheraSphere GBM treatment utilizes intra-arterial deli [...]
Study sitescontacts updated at 1 of 5 sites
2022-09-14
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteriarevised
[...] treatment with combination of radiotherapy and chemotherapy +± Tumor Treating Fields (Optune®) Prior cranial radiation dos [...]
Study sitescontacts updated at 1 of 5 sites
2022-08-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-07-29→confirmed 2022-07-30
Study sites0→5
2022-07-18
Study Status v2
Start date2022-07-01→2022-07-29
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.
Trial Details
NCT Number NCT05303467
Lead Sponsor Boston Scientific Corporation
Conditions Glioblastoma Multiforme, Recurrent Glioblastoma
Enrollment 36 participants
Start Date 2022-07-30
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-28