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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Boston Scientific Corporation
Study ID
NCT05303467
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TheraSphere GBM — DEVICE
    Single treatment of TheraSphere GBM device

Study Details

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.

Key Dates

Start date
Jul 30, 2022
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A
    Subjects in which the perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
  • Experimental: Treatment Group B
    Subjects in which the perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
  • Experimental: Treatment Group C
    Subjects in which the perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
  • Experimental: Treatment Group D
    Subjects in which the perfused volume encompasses the dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

Primary Outcome Measure

The number of grade 3-5 non-hematological toxicities [ Time Frame: 30 days post index procedure ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294-
University of California San DiegoSan DiegoCalifornia92103
Sheila Medina Torne
[email protected]
858-822-6100
Zachary Berman, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Stephanie Lewis
[email protected]
415-353-2193
Nicholas Butowski, MD (PRINCIPAL_INVESTIGATOR)
Mayo JacksonvilleJacksonvilleFlorida32224
Aleeshba Basil
[email protected]
855-776-0015
Alfredo Quinones-Hinojosa, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniverityChicagoIllinois60611
Roger Stupp, MD
[email protected]
866-587-4322
Emily R Powell
[email protected]
312-926-3872
Samdeep Mouli, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Interventional Radiology CenterBaltimoreMaryland21287-
Washington University School of MedicineSt LouisMissouri63130
Arindam Chatterjee, M.D. (PRINCIPAL_INVESTIGATOR)
Lenox Hill HospitalNew YorkNew York10075
Tamika Wong
[email protected]
212-434-4836
John Boockvar, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Summer Stovall
[email protected]
713-745-4243
Stephen Chen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama Birmingham· Birmingham, ALUniversity of California San Diego· San Diego, CAUniversity of California San Francisco· San Francisco, CAMayo Jacksonville· Jacksonville, FLNorthwestern Univerity· Chicago, ILJohns Hopkins Interventional Radiology Center· Baltimore, MD

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