Advances in Radioembolization for Liver Cancer.
Sam Meiselman, M Allan Thomas, J Daniel Giardina...
https://pubmed.ncbi.nlm.nih.gov/41276366Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05303467
FRONTIER: A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma Device in Patients With Recurrent GBM
Led by Boston Scientific Corporation · Updated on 2026-06-01
36
Participants Needed
9
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Glioblastoma (GBM) is an aggressive brain cancer with a very low five-year survival rate, and current treatments like external beam radiotherapy (EBRT) are limited by side effects. Researchers are studying the TheraSphere GBM Y-90 Glass Microsphere System, a targeted internal radiation therapy, to assess its safety and technical feasibility in treating patients with recurrent GBM. This early feasibility study aims to explore whether this localized treatment can reduce side effects and improve quality of life compared to existing options. The study uses the TheraSphere GBM device, which delivers yttrium-90 glass microspheres directly into the arteries feeding the tumor via catheter placement. Treatment targets different brain regions based on tumor location, with a projected radiation dose of 40 Gy ±10%. The trial includes four treatment groups depending on whether the perfused volume includes the dominant or non-dominant hemisphere and involvement of eloquent brain regions. This single-arm, interventional study evaluates one treatment session per participant. Participants will undergo angiographic mapping to identify tumor blood supply and treatment volume before receiving the device. The research team will monitor safety by tracking serious toxicities and neurological function using scales like NIH Stroke Scale and modified Rankin Scale for up to six months. Imaging and clinical assessments will evaluate treatment delivery success, tumor response, progression-free survival, and overall survival. The study expects participants to comply with follow-up visits and testing over this period to measure outcomes and side effects.
CONDITIONS
Brief Title
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant is 18 years or older and has signed the informed consent form
- Life expectancy of at least 12 weeks
- Willing and able to follow the trial procedures and schedule
- Histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
- Radiographic evidence of tumor progression or recurrence with measurable disease (1 to 5 cm by MRI)
- Prior surgery and treatment with radiotherapy and chemotherapy with or without Tumor Treating Fields
- Prior cranial radiation dose less than 66 Gy
- WHO performance status of 2 or less
- At least 6 months since completion of cranial radiotherapy, or 12 weeks if recurrence outside prior radiation field
- At least 1 treatment cycle or appropriate biological half-lives since last systemic therapy
- Stable or decreasing steroids dose equivalent to dexamethasone 6 mg/day for at least 7 days
- Adequate organ and bone marrow function within 14 days prior to registration
- Negative pregnancy test within 14 days prior to registration (for females of child-bearing potential)
- Male or non-pregnant female; females of child-bearing potential must use birth control if sexually active
- Accessible neurovascular anatomy for safe catheter placement to treat tumor
- Total treatment volume of 150 cc or less
- Perfused volume falls into one of the specified brain region groups (non-dominant/dominant hemisphere and eloquent/non-eloquent regions)
You will not qualify if you...
- Bilateral gadolinium enhancing disease or tumor in critical brain areas such as brainstem or optic chiasma
- More than 1 prior course of cranial radiotherapy
- Prior radiosurgery, brachytherapy, or hypofractionated radiotherapy
- More than 2 systemic treatment protocols excluding maintenance temozolomide
- Prior intra-arterial cerebral infusion therapy
- More than 2 prior surgical procedures related to glioblastoma
- Prior thoracic radiation therapy
- Increased risk of wound healing problems or infections
- Uncontrolled epilepsy
- Severe or uncontrolled illnesses including uncontrolled hypertension, unstable cardiac disease, severe pulmonary hypertension, pulmonary insufficiency, active infections, pneumonitis, psychiatric issues limiting compliance, or peripheral neuropathy grade 1 or higher
- Currently pregnant or breastfeeding (unless breastfeeding is stopped)
- History of active other malignancy within 1 year prior to registration (with some exceptions)
- History of ischemic cerebral disease or risk of cerebral herniation
- Contraindication to contrast-enhanced MRI
- Known allergies to iodinated or gadolinium-based contrast agents
- Received investigational agents within 4 weeks or participation in conflicting trials
- Significant vascular disease or anatomical issues precluding safe vascular access for treatment delivery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single day
Participants receive a single treatment with the TheraSphere GBM device involving intra-arterial delivery of yttrium-90 glass microspheres targeting the tumor.
1 treatment visit (in-person)
Follow-up
Duration - Up to 6 months post treatment
Participants are monitored for safety, neurological function, and treatment outcomes for up to 6 months after the treatment.
Multiple follow-up visits over 6 months
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
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Research Team
S
Sally Linda
L
Lilian Liu Pan
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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