Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma

NCT07712770 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: ONJ2025-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new way of treating brain tumours using tiny radioactive beads called SIR-Spheres® (90Y-labelled Resin Microspheres). These microspheres are placed into the blood vessels that feed the tumour. The treatment gives off radiation inside the tumour to try to stop it from growing. This type of treatment is called Selective Internal Radiation Therapy (SIRT), Transarterial Radioembolisation (TARE), or radioembolisation. It is already an accepted treatment for patients with liver cancer. In this study, we are testing if this treatment can be done safely in the brain and how well it works.

Conditions

Recurrent Glioblastoma; Recurrent Glioblastoma IDH Wildtype

Keywords

glioblastoma; SIR-spheres; Selective Internal Radiation Therapy; SIRT; Transarterial Radioembolisation; TARE; radioembolisation

Outcome Measures

Primary Outcomes (3)

• Safety - Treatment-related adverse events

  Rate of any treatment-related adverse events within the first 30 days after TARE, according to CTCAE, version 6.0.

  From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.

• Safety - Severe treatment-related adverse events

  Rate of any severe treatment-related adverse events (grade ≥3-5) within the first 30 days after TARE, according to CTCAE version 6.0

  From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.

• 30-day mortality

  Rate of all-cause mortality within 30 days following TARE.

  From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.

Secondary Outcomes (9)

• Technical success of TARE

  6 months after the last patient has been enrolled

• Confirmation of dose delivery

  6 months after the last patient has been enrolled.

• Objective response rate (ORR)

  6 months after the last patient has been enrolled

• Disease control rate (DCR)

  6 months after the last patient has been enrolled

• Clinical and radiographic progression-free survival (PFS)

  6 months after the last patient has been enrolled

Other Outcomes (3)

• To evaluate the correlation between organ at risk radiation dosimetry and adverse events

  6 months after the last patient has been enrolled

• To evaluate the concordance between pre-treatment predicted and post-treatment delivered absorbed dose distributions to tumour and normal brain using voxel-based dosimetry

  6 months after the last patient has been enrolled

• To investigate circulating biomarkers and potential mechanisms of resistance, for patients treated with this approach.

  6 months after the last patient has been enrolled

Study Arms (1)

Intervention

EXPERIMENTAL

SIR-Spheres® will be administered intra-arterially by selective catheterisation of tumour-feeding arteries. The prescribed activity will be determined on an individual basis. The administered activity of SIR-Spheres® will be selected to achieve adequate coverage of the target, taking into account tumour burden within the treated volume, while keeping dose to normal brain within acceptable limits.

Device: SIR-Spheres®

Interventions

SIR-Spheres® DEVICE

Single administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated

Also known as: 90Y-labelled Resin Microspheres

Intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years at the time of screening
• Histomolecular diagnosis of IDH-wildtype glioblastoma (as per WHO 2021)
• Prior treatment with radiotherapy and an alkylating agent
• Presence of measurable disease on brain MRI, as defined by RANO 2.0 criteria
• Radiologically confirmed disease progression as per RANO 2.0 criteria
• Lesion confined to a single focus, with a maximum diameter ≤6 cm, and located in a vascular territory amenable to selective intra-arterial catheterisation as assessed on baseline imaging and confirmed by planning angiography, cone beam CT, and \[99mTc\]Tc-MAA SPECT/CT (where available)
• Stable neurological status; patients with epilepsy may be included if seizures are controlled on a stable dose of anti-epileptic medication
• ECOG performance status 0-2
• Estimated life expectancy of ≥3 months, in the opinion of the investigator
• Adequate haematologic, renal, hepatic, and coagulation function at screening, defined as:
• Haemoglobin ≥9 g/dL
• Absolute neutrophil count ≥1.5 x 109/L
• Platelet count ≥100 x 109/L
• Serum creatinine ≤1.5 x ULN, or creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
• Total bilirubin ≤1.5 x ULN (except patients with known Gilbert's syndrome)

You may not qualify if:

• Multifocal glioma recurrence
• Tumour located in the posterior fossa or involving/risking critical subcortical structures (e.g. thalamus, hypothalamus, basal ganglia, internal capsule, cerebral peduncle, midbrain, brainstem, or optic pathways)
• Prior treatment with VEGF inhibitors
• Prior re-irradiation for progressive or recurrent disease
• Any local (surgery or radiotherapy) or systemic anti-cancer therapy within 28 days prior to the planned dose of the investigational treatment
• Concurrent use of any anti-cancer therapies, investigational drugs, or biological agents not specified in the protocol
• Contraindications to MRI, including but not limited to non-compatible implantable devices or severe claustrophobia
• Contraindications to catheter-based angiography, including but not limited to known bleeding disorders, significant vascular abnormalities precluding safe access, and severe allergy to contrast agents
• Pregnancy or breastfeeding. Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for at least 4 months after the last procedure.
• Any severe or uncontrolled medical condition that, in the investigator's judgement, would pose an unacceptable risk to the patient or interfere with protocol compliance
• Cognitive or psychiatric conditions that would limit the ability to provide informed consent or adhere to study procedures
• Known hypersensitivity or allergy to 90Y-resin microspheres or any component of the investigational product

Sponsors & Collaborators

• Austin Health: collaborator
• Olivia Newton-John Cancer Research Institute: lead

Study Sites (1)

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

AU (1)