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

NCT07867886 | Not Yet Recruiting DMC

• 2 other identifiers: S2526CIV-2025-11-055434
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

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)

Outcome Measures

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.

  Through the 30-day observation period from the index procedure.

Secondary Outcomes (21)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

Y90 GBM Device Treatment

EXPERIMENTAL

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

Device: TheraSphere GBM treatment of TheraSphere GBM device 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

Y90 GBM Device Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Hypertension grade 3 or higher without adequate control on medications
• Symptomatic or unstable cardiac disease,
• Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
• Psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• IQVIA RDS Inc.: collaborator

Study Sites (5)

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, 69500, France

Location

Hôpital de La Timone

Marseille, 13005, France

Location

Universitätsklinikum Tübingen

Tübingen, 72074, Germany

Location

University Medical Center Utrecht

Utrecht, 3584, Netherlands

Location

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 28, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); DE (1); FR (2); ES (1)