Recurrent Glioblastoma IDH WildtypeEarly Phase 1PRECISENCT07712770
Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma
A Early Phase 1 study testing SIR-Spheres® in people with Recurrent Glioblastoma IDH Wildtype and Recurrent Glioblastoma, run by Olivia Newton-John Cancer Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma IDH Wildtype, Recurrent Glioblastoma
- What is being tested?
- SIR-Spheres®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
- 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
- Ability to understand and comply with study requirements and provide written informed consent.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Austin Hospital
Melbourne, Victoria, 3084
Hui Gan Professor, MBBS, PhD in Medical Oncology, 03 9496 3088, Hui.gan@austin.org.au
About this study
Official title: 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.
Read the 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.
- Being tested
- SIR-Spheres®
- Keywords
- glioblastoma, SIR-spheres, Selective Internal Radiation Therapy, SIRT, Transarterial Radioembolisation, TARE, radioembolisation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR-Spheres®Device
Also called 90Y-labelled Resin Microspheres
Single administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SIR-Spheres® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after the last patient has been enrolled
Overall survival (OS)
Overall survival (OS)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Assessed up to 6 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma IDH WildtypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712770
- Sponsor's protocol ID
- ONJ2025-001
- Acronym
- PRECISE
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing to occur at publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma (PRECISE)
- ClinicalTrials.gov ID
- NCT07712770
- Acronym / sponsor ID
- PRECISE / ONJ2025-001
- Keywords
- glioblastoma, SIR-spheres, Selective Internal Radiation Therapy, SIRT, Transarterial Radioembolisation, TARE, radioembolisation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Olivia Newton-John Cancer Research InstituteUniversity, hospital or other
- Collaborators
- Austin Health
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: SIR-Spheres®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIR-Spheres®Also: 90Y-labelled Resin MicrospheresSingle administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated | Device | Intervention |
Primary outcome
Safety - Treatment-related adverse events
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Rate of any treatment-related adverse events within the first 30 days after TARE, according to CTCAE, version 6.0.
Safety - Severe treatment-related adverse events
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Rate of any severe treatment-related adverse events (grade ≥3-5) within the first 30 days after TARE, according to CTCAE version 6.0
30-day mortality
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Rate of all-cause mortality within 30 days following TARE.
9 secondary outcomes
Technical success of TARE
Time frame: 6 months after the last patient has been enrolled
Confirmation of dose delivery
Time frame: 6 months after the last patient has been enrolled.
Objective response rate (ORR)
Time frame: 6 months after the last patient has been enrolled
Disease control rate (DCR)
Time frame: 6 months after the last patient has been enrolled
Clinical and radiographic progression-free survival (PFS)
Time frame: 6 months after the last patient has been enrolled
Overall survival (OS)
Time frame: 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).
Time frame: 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).
Time frame: Assessed up to 6 months after enrolment
Safety following repeat administration of SIR-Spheres® administration
Time frame: Assessed up to 6 months after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data sharing to occur at publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SIR-Spheres® in people with Recurrent Glioblastoma IDH Wildtype and Recurrent Glioblastoma, run by Olivia Newton-John Cancer Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Treatment-related adverse events (time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.