Inclusion Criteria:
1. Subject is 18 years or older and has signed and dated the trial informed consent
form (ICF)
2. Life expectancy ≥ 12 weeks. 3. Subject is willing and able to comply with the trial testing, procedures, and
follow-up schedule. 4. History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO
criteria. 5. Have radiographic evidence of tumor progression/recurrence with measurable disease
(≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according
to RANO criteria. 6. Prior surgery and treatment with combination of radiotherapy and chemotherapy ±
Tumor Treating Fields (Optune®)
7. Prior cranial radiation dose < 66 Gy. 8. WHO performance status ≤ 2. 9. The interval since completion of cranial radiotherapy must be > 6 months, unless
there is tissue confirmation of tumor recurrence/progression outside the previous
radiation treatment field, in which case the interval since completion of cranial
radiation must be at least 12 weeks. 10. Interval since last systemic therapy until presumed date of intervention ≥ 1 cycle
or ≥ 2 biological half-lives, i.e.
1. ≥ 4 weeks since last dose of temozolomide. 2. ≥ 6 weeks since last dose of lomustine or other nitrosourea. 3. ≥ 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase
Inhibitor or similar)
4. ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other
antibody-based VEGF therapy. 11. If receiving steroids, patient should be on a stable or decreasing dose equivalent
to dexamethasone ≤ 6 mg/d, for at least 7 days prior to registration. 12. Have adequate organ and bone marrow function within 14 days prior to registration,
as defined below:
1. INR ≤ 1.2 (in absence of anticoagulation)
2. Platelets ≥ 100,000/L. 3. Creatinine ≤1.5 mg/dL. 4. Absolute Neutrophil Count ≥1.5 x 10^9/L. 5. Hemoglobin ≥9.0 g/dL. 13. Have a negative pregnancy test within 14 days prior to registration on study (for
FOCBP, female of child-bearing potential)
14. Subject is a male or non-pregnant female. If female of child-bearing potential, and
if sexually active must be using, or agree to use, a medically acceptable method of
birth control as confirmed by the investigator. 15. Angiographic Mapping
Inclusion Criteria:
1. Accessible neurovascular anatomy that allows for safe microcatheter placement
(up to two locations) to infuse TheraSphere GBM to treat all of the T1
enhancing component of target lesion confirmed by neuro-interventional team.
2. Total treatment volume is ≤ 150cc as determined by multidisciplinary team.
16. Additional
Inclusion Criteria:
1. Group A: perfused volume encompasses the non-dominant hemisphere and
non-eloquent regions of the brain. 2. Group B: perfused volume encompasses the non-dominant hemisphere and eloquent
regions of the brain. 3. Group C: perfused volume encompasses the dominant hemisphere and non-eloquent
regions of the brain. 4. Group D: perfused volume encompasses the dominant hemisphere and eloquent
regions of the brain.
Exclusion Criteria:
1. Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa,
tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain,
brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor
approximating or invading the brainstem and/or optic chiasma, leptomeningeal
disease, or extracranial metastatic disease. 2. Have received more than 1 course of prior cranial radiotherapy (EBRT)
3. Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy. 4. Have received more than 2 systemic treatment protocols (lines of treatment), not
including maintenance temozolomide. 5. Have received prior intra-arterial cerebral infusion therapy. 6. Have received more than 2 surgical GBM-related procedures. 7. Have received prior thoracic radiation therapy. 8. Are at increased risk of wound dehiscence by the discretion of the investigators
(e.g. brain surgery within the last 3 months, poor skin condition, and/or previously
infected surgical field or any other condition that is of increased infectious risk
in the opinion of the neurosurgeon)
9. Have uncontrolled epilepsy. 10. Have severe and/or insufficiently controlled intercurrent illness; patients with the
following are not eligible:
1. Hypertension grade 3 or higher without adequate control on medications. 2. Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or
severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg)
3. Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of < 60 mmHg, or
oxygen saturation (Sa,O2) of < 90%) as measured by fingertip pulse oximeter. 4. Ongoing or active bacterial or viral infection requiring systemic treatment
(including HIV)
5. Pneumonitis. 6. Psychiatric illness/social situations that would limit compliance with study
requirements. 7. Peripheral Neuropathy ≥ grade 1. 8. Any other illness or condition that the treating investigator feels would
interfere with study compliance or would compromise the patient's safety, study
endpoints or longevity. 11. Are currently pregnant or breast feeding (unless patient agrees to stop
breastfeeding)
12. Patients with a history of an active other malignancy within 1 year prior to
registration. NOTE: Exceptions to this requirement include adequately treated
non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of
disease, or recurrent glioblastoma. 13. Patients with a history of ischemic cerebral disease and/or at risk of cerebral
herniation. 14. Medical contraindication to undergo contrast-enhanced magnetic resonance imaging
(MRI)
15. Known history of hypersensitivity reactions to iodinated and/or gadolinium-based
contrast. 16. Subject has received any other investigational agents within 4 weeks of treatment,
or is 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)
17. Angiographic Mapping
Exclusion Criteria:
Patients with significant vascular disease,
significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe
or feasible vascular access
