Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma (PRECISE)

Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma (PRECISE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Glioblastoma; Recurrent Glioblastoma IDH Wildtype
• Intervention / Treatment: Device: SIR-Spheres®

Detailed Description

This study is testing a new approach to treat people with the most aggressive type of adult brain tumour, glioblastoma. It will determine whether a treatment called selective internal radiation therapy (SIRT) (also know as Transarterial Radioembolisation (TARE), or radioembolisation) is safe and effective in patients with recurrent or progressive glioblastoma. Small radioactive beads (SIR-Spheres®) are administered directly into the blood vessels that feed the tumour. This aims to selectively damage cancer cells and spare healthy tissue. PRECISE will investigate whether SIRT may reduce the volume of the tumour or slow its growth. Participants will undergo a detailed assessment to confirm they are suitable for the treatment. Those enrolled will have a planning procedure to map the blood vessels supplying the tumour, followed by SIRT treatment. Participants will also have scans and medical follow-ups after the procedure to monitor how they are going and whether the treatment is working. Safety of participants will be closely monitored by a team of specialist doctors. This study may represent the initial step towards a new treatment option for people with gliomas, who currently have very few alternatives once standard treatments have failed.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Hospital
      • Contact: Hui Gan Professor, MBBS, PhD in Medical Oncology; Phone Number: 03 9496 3088; Email: Hui.gan@austin.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years at the time of screening
2. Histomolecular diagnosis of IDH-wildtype glioblastoma (as per WHO 2021)
3. Prior treatment with radiotherapy and an alkylating agent
4. Presence of measurable disease on brain MRI, as defined by RANO 2.0 criteria
5. Radiologically confirmed disease progression as per RANO 2.0 criteria
6. 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)
7. Stable neurological status; patients with epilepsy may be included if seizures are controlled on a stable dose of anti-epileptic medication
8. ECOG performance status 0-2
9. Estimated life expectancy of ≥3 months, in the opinion of the investigator

10. 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)
    • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5 x ULN
    • International normalized ratio (INR) ≤1.5 x ULN
    • Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN
11. Ability to understand and comply with study requirements and provide written informed consent.

Exclusion Criteria:

1. Multifocal glioma recurrence
2. 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)
3. Prior treatment with VEGF inhibitors
4. Prior re-irradiation for progressive or recurrent disease
5. Any local (surgery or radiotherapy) or systemic anti-cancer therapy within 28 days prior to the planned dose of the investigational treatment
6. Concurrent use of any anti-cancer therapies, investigational drugs, or biological agents not specified in the protocol
7. Contraindications to MRI, including but not limited to non-compatible implantable devices or severe claustrophobia
8. 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
9. 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.
10. 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
11. Cognitive or psychiatric conditions that would limit the ability to provide informed consent or adhere to study procedures
12. Known hypersensitivity or allergy to 90Y-resin microspheres or any component of the investigational product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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®; Single administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated; Other Names: 90Y-labelled Resin Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success of TARE	Technical success rate, defined as successful selective catheterisation and administration of SIR-Spheres® to the target volume without significant non-target deposition.	6 months after the last patient has been enrolled
Confirmation of dose delivery	Confirmation of dose delivery to the target volume as assessed by post-treatment PET/CT.	6 months after the last patient has been enrolled.
Objective response rate (ORR)	Objective response rate (ORR) according to RANO 2.0 and PET RANO 1.0 criteria.	6 months after the last patient has been enrolled
Disease control rate (DCR)	Disease control rate (DCR) according to RANO 2.0 and PET RANO 1.0 criteria.	6 months after the last patient has been enrolled
Clinical and radiographic progression-free survival (PFS)	Clinical and radiographic progression-free survival (PFS) according to NANO, RANO 2.0 and PET RANO 1.0 criteria.	6 months after the last patient has been enrolled
Overall survival (OS)	Overall survival (OS)	Up to 6 months after the last patient has been enrolled.
Change from baseline in health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).	The EORTC QLQ-C30 consists of multi-item functional and symptom scales transformed to scores ranging from 0 to 100. Higher scores indicate better functioning/global health status on the functional and global health scales, whereas higher scores indicate worse symptom burden on the symptom scales.	Assessed up to 6 months after enrolment
Change from baseline in brain cancer-specific quality of life measured using the European Organisation for Research and Treatment of Cancer Brain Neoplasm Module (EORTC QLQ-BN20).	The EORTC QLQ-BN20 comprises symptom scales transformed to scores ranging from 0 to 100, with higher scores indicating greater symptom burden (worse quality of life).	Assessed up to 6 months after enrolment
Safety following repeat administration of SIR-Spheres® administration	Rate and severity of treatment-related adverse events in participants who proceed to a second SIR-Spheres® administration compared with participants receiving a single administration.	Assessed up to 6 months after enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the correlation between organ at risk radiation dosimetry and adverse events	Correlation between absorbed dose (Gy) to normal brain, as estimated on post-treatment 90Y PET, and the incidence of treatment-related adverse events, as classified by CTCAE version 6.0	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	Correlation between absorbed dose estimates to tumour and normal brain derived from pre-treatment [99mTc]Tc-MAA SPECT/CT and post-treatment 90Y PET 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.	Change in circulating biomarker levels from baseline over time, including the identification of molecular or cellular markers associated with treatment response or resistance.	6 months after the last patient has been enrolled

Collaborators and Investigators

• Sponsor: Olivia Newton-John Cancer Research Institute
• Collaborators: Austin Health

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: glioblastoma; SIRT; Selective Internal Radiation Therapy; TARE; radioembolisation; SIR-spheres; Transarterial Radioembolisation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: ONJ2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing to occur at publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No