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Not yet recruitingNCT07867886ODYSSEYUpdated Oct 9, 2026

An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM

An interventional study of Device: TheraSphere GBM treatment of TheraSphere GBM device in Recurrent Glioblastoma, sponsored by Boston Scientific Corporation. Not yet recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease. The study will look at the safety of the Y90 glass microsphere device and if it works to help stop the growth of the tumor.

In this study, the device is delivered directly to the tumor through the blood vessels/arteries using a catheter(s) (a specialized tubing). The device (very small glass beads) gives radiation directly to the tumor and nearby area.

Although radiation is a standard treatment for most types of brain cancer, the delivery of radiation using the Y90 glass microsphere device differs and is an investigational procedure. To deliver the device a catheter(s) will be inserted through a blood vessel/artery in the forearm or groin, followed by an in-hospital stay after the treatment of up-to 36 hours. Participants will have regular follow-up visits with the study doctor to monitor their health and assess how the tumor responds to treatment. These visits will take place weekly during the first month, monthly for the next five months, and then approximately every two months until one year after treatment.

02

Conditions studied

  • Recurrent Glioblastoma

Keywords

  • Glioblastoma
  • Glioblastoma Multiforme (GBM)
  • Recurrent Glioblastoma
  • Recurrent GBM
  • Brain Neoplasms
  • Malignant Glioma
  • Yttrium-90
  • Y-90
  • Radioembolization
  • Brachytherapy
  • Intratumoral Radiation
  • Localized Radiation Therapy
  • Neuro-Oncology
  • Recurrent Brain Tumor
  • Neurovascular Radiotherapy (NVRT)
03

In context

Glioblastoma

1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 1,645 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Browse Boston Scientific Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
  • Life expectancy ≥ 12 weeks
  • Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
  • History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
  • Have radiographic evidence of measurable tumor progression/recurrence according to RANO 2.0 criteria
  • Target lesion volume does not exceed 70 cm\^3
  • Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)
  • ECOG performance status ≤ 2
  • The interval since completion of external beam cranial radiotherapy must be > 6 months, unless there is 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

  • Interval since last systemic therapy until index procedure

    1. ≥ 4 weeks since last dose of temozolomide
    2. ≥ 4 weeks since last dose of lomustine or other nitrosourea
    3. ≥ 2 weeks since last dose of any oral targeted therapy (Tyrosine Kinase inhibitor or similar)
    4. ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based anti VEGF therapy
    5. ≥ 4 weeks since last dose of investigational agents or patient has on-going \< Grade 2 AEs related to investigational agent.
  • 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 index procedure

  • Have adequate organ and bone marrow function within 14 days prior to index procedure, as defined below:

    1. INR ≤ 1.5 (in absence of anticoagulation)
    2. Platelets ≥ 75,000/L
    3. Creatinine ≤1.5 mg/dL
    4. Absolute Neutrophil Count ≥1.5 x 109/L
    5. Hemoglobin ≥9.0 g/dL

  • For female of child-bearing potential:

    1. Have a negative pregnancy test within 14 days prior to index procedure
    2. If sexually active must be using, or agree to use, an acceptable method of birth control as confirmed by the investigator for the duration of their participation in the study
    3. If currently breastfeeding, must agree to stop breastfeeding
  • Angiographic Criteria:

The intent of therapy should be to encompass the entire radiographically defined target lesion within the PV b. Each PV is ≤ 150cc, with the total PV not exceeding 400cc

Exclusion criteria

Exclusion Criteria:

None of the following exclusion criteria can be met:

  • Have leptomeningeal disease or other primary malignancy metastatic to the brain
  • Target lesion located in or involving the infratentorial space, thalamus, hypothalamus, internal capsule, or optic chiasma
  • Have received more than 1 course of prior cerebral radiotherapy (EBRT)
  • Prior cranial radiation dose ≥ 66 Gy
  • Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
  • Have received more than 2 systemic anti-tumor treatment protocols (lines of treatment), not including neoadjuvant or adjuvant temozolomide (oral or IV)
  • Have received more than 2 surgical GBM-related procedures
  • Patients with a history of stroke, ischemic cerebral disease, and/or at risk of cerebral herniation
  • Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. recent brain surgery, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the treatment team)
  • Have uncontrolled epilepsy

  • 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,
    3. Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
    4. Psychiatric illness/social situations that would limit compliance with study requirements
    5. Peripheral Neuropathy ≥ grade 1
    6. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
  • Patients with a history of an active other malignancy within 1 year prior to index procedure. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or carcinoma in situ without evidence of disease
  • Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)
  • Known history of severe uncorrectable reactions to iodinated and/or gadolinium-based contrast
  • Subject 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).
  • Angiographic Criteria: Patients with evident AV shunting, vascular disease or tortuosity precluding safe or feasible vascular access, or patient vasculature not conducive to delivery of the therapy on baseline imaging or angiography.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Y90 GBM Device Treatment

    Subjects are eligible if each treatment area supplied by a targeted blood vessel (perfused volume, PV) is 150 cc or less, and the total perfused volume does not exceed 400 cc. This is a dose-escalation study designed to determine the safest and most appropriate radiation dose. The planned radiation dose to the treatment area ranges from 60 Gy to 120 Gy. The study will begin at a dose of 60 Gy, with dose increases of 20 Gy for subsequent patient groups. Patients will be treated in groups of three at each dose level. If a particular dose level is found to be safe, the next group of patients may receive the next higher dose level, stay at the same dose level, or de-escalate the dose level depending on the rate of Dose Limiting Toxicities and Data Monitoring Committee determination.

    Device: Device: TheraSphere GBM treatment of TheraSphere GBM device

Interventions

  • DeviceDevice: TheraSphere GBM treatment of TheraSphere GBM device

    All patients participating in the study will receive the same device. The study is evaluating the safety and efficacy of the device when it is used to deliver radiation to the area of the brain containing the tumor. The amount of radiation a patient receives depends on the dose group (cohort) to which they are assigned. Patients will be treated in groups of three at each dose level. If a dose level is considered safe, the next group of patients will receive a higher dose

06

What researchers measure

Primary outcomes

  1. Maximum tolerated radiation absorbed dose (MTRAD) of the Y90 microspheres device to the perfused volume (PV) corresponding to a DLT of smaller equals 33%

    The MTRAD of Y-90 microspheres to the PV corresponding to a Dose Limiting Toxicity (DLT) rate of ≤33% through 30 days observation period from the index procedure. A DLT is defined as any device-related ≥Grade 3 adverse event, excluding radiographic-only cerebral edema and symptomatic cerebral edema if symptoms improve within 7 days of initiation of medical management.

    Time frame: Through the 30-day observation period from the index procedure.

Secondary outcomes

  1. Rate of Adverse Events (AEs) throughout follow up period (any causality, severity, and duration):

    Time frame: From mapping procedure through study follow-up, assessed for up to 36 months

  2. Rate of radiation-related neurotoxicity throughout follow up period (any causality, severity, and duration)

    Time frame: From mapping procedure through study follow-up, assessed for up to 36 months

  3. Rate of Serious AEs throughout follow up period (any causality, severity, and duration)

    Time frame: From mapping procedure through study follow-up, assessed for up to 36 months

  4. Rate of procedure-related AEs throughout follow up period (any causality, severity, and duration)

    Time frame: From mapping procedure through study follow-up, assessed for up to 36 months

  5. Rate of device-related AEs throughout follow up period (any causality, severity, and duration)

    Time frame: From mapping procedure through study follow-up, assessed for up to 36 months

  6. Disease Control Rate, overall (DCR)

    Time frame: From enrollment through 12 month following treatment

  7. Disease Control Rate within the PV (DCR)

    Time frame: From enrollment through 12 month following treatment

  8. Progression Free Survival, overall (PFS)

    Time frame: From enrollment for up to 36 months

  9. Progression Free Survival within the PV (PFS)

    Time frame: From enrollment until disease progression or death, assessed for up to approximately 36 months

  10. Overall Survival (OS)

    Time frame: From enrollment for up to 36 months.

  11. Time to subsequent anticancer treatment

    Time frame: From date of index procedure through the 12 month visit

  12. Change from baseline in Quality of Life (QoL) scores per EORTC QLQ-C30

    Time frame: From Screening to 6 month visit

  13. Change from baseline in Quality of Life (QoL) score per EORTC QLQ-BN20

    Time frame: From Screening to 6 month visit

  14. Change from baseline in neurocognitive function as measured by Hopkins Verbal Learning Test (HVLT-R).

    Time frame: From Screening to 6 month visit

  15. Change from baseline in neurocognitive function as measure by Trail Making Test A (TMTA)

    Time frame: From Screening to 6 month visit

  16. Change from baseline in neurocognitive function as measure by Trail Making Test B (TMTB)

    Time frame: From Screening to 6 month visit

  17. Change from baseline in neurocognitive function as measured by Controlled Oral Word Association (COWA)

    Time frame: From Screening to the 6 month visit

  18. Change from baseline in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS)

    Time frame: From Screening to 12 month visit

  19. Change form baseline in post-treatment neurological function as assessed by Modified Rankin Score (MRS)

    Time frame: From Screening to 12 month visit

  20. Relationship between absorbed dose to PV and safety

    Time frame: From enrollment through the 12 month period following treatment

  21. Relationship between absorbed dose to PV and efficacy endpoints

    Time frame: From enrollment through 12 month period following treatment

07

Study locations

5 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 147 interventional studies with no phase under Glioblastoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 88. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Oct 9, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Oct 28, 2028
CompletionEst.
Sep 30, 2029
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07867886
Lead sponsor
Boston Scientific Corporation
Collaborators
IQVIA RDS Inc.
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 28, 2028 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Oct 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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