Actively Recruiting
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Led by Boston Scientific Corporation · Updated on 2026-04-29
36
Participants Needed
9
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with signed informed consent
- Life expectancy of at least 12 weeks
- Willing and able to comply with study procedures and follow-up
- Histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
- Radiographic evidence of tumor progression or recurrence with measurable disease (1 to 5 cm diameter) by MRI
- Prior surgery and treatment with radiotherapy and chemotherapy with or without Tumor Treating Fields (Optune�)
- Prior cranial radiation dose less than 66 Gy
- WHO performance status of 2 or less
- At least 6 months since completion of cranial radiotherapy unless recurrence is outside prior radiation field, then at least 12 weeks
- At least 1 cycle or appropriate biological half-lives since last systemic therapy (4 weeks for temozolomide, 6 weeks for lomustine/nitrosourea, 2 weeks for small molecule agents, 6 weeks for antibody therapies)
- Stable or decreasing steroid dose equivalent to dexamethasone 6 mg/day or less for at least 7 days before registration
- Adequate organ and bone marrow function within 14 days before registration (INR �� 1.2 without anticoagulation, platelets �� 100,000/L, creatinine �� 1.5 mg/dL, neutrophil count �� 1.5 x 10^9/L, hemoglobin �� 9.0 g/dL)
- Negative pregnancy test within 14 days before registration for females of child-bearing potential
- Male or non-pregnant female; females of child-bearing potential must use acceptable birth control if sexually active
- Accessible neurovascular anatomy allowing safe catheter placement to treat all enhancing tumor
- Total treatment volume 150 cc or less
- Perfused volume classification groups A, B, C, or D based on brain hemisphere and eloquence involvement
You will not qualify if you...
- Bilateral gadolinium enhancing disease, tumor in posterior fossa, or involving critical subcortical structures or brainstem
- Tumor invading brainstem or optic chiasma, leptomeningeal disease, or extracranial metastases
- More than one prior course of cranial radiotherapy
- Previous radiosurgery, brachytherapy, or hypofractionated radiotherapy
- More than two systemic treatment protocols (excluding maintenance temozolomide)
- Prior intra-arterial cerebral infusion therapy
- More than two surgical procedures related to GBM
- Prior thoracic radiation therapy
- Increased risk of wound complications (e.g., recent brain surgery, poor skin condition, infected surgical field)
- Uncontrolled epilepsy
- Severe or uncontrolled illnesses including grade 3 or higher hypertension, unstable cardiac disease, severe pulmonary hypertension, pulmonary insufficiency, active infections, pneumonitis, psychiatric illness limiting compliance, grade 1 or higher peripheral neuropathy, or other conditions compromising safety or compliance
- Pregnant or breastfeeding (unless breastfeeding is stopped)
- History of another active malignancy within one year except certain skin cancers or recurrent GBM
- History of ischemic cerebral disease or risk of cerebral herniation
- Contraindications to contrast-enhanced MRI
- Known hypersensitivity to iodinated or gadolinium contrast
- Use of investigational agents within 4 weeks or participation in conflicting trials
- Significant vascular disease or anatomical issues preventing safe catheter access during angiographic mapping
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Withdrawn
2
University of California San Diego
San Diego, California, United States, 92103
Not Yet Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Mayo Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Northwestern Univerity
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Johns Hopkins Interventional Radiology Center
Baltimore, Maryland, United States, 21287
Withdrawn
7
Washington University School of Medicine
St Louis, Missouri, United States, 63130
Actively Recruiting
8
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
S
Sally Linda
CONTACT
L
Lilian Liu Pan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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