Radioactive beads take aim at brain tumours
NCT ID NCT07712770
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This early-phase trial tests a new way to treat recurrent glioblastoma, an aggressive brain cancer. Tiny radioactive beads called SIR-Spheres® are injected into the blood vessels feeding the tumour to deliver radiation directly inside it. The study aims to see if this approach is safe and can slow tumour growth in people whose cancer has returned after standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tiny radioactive beads called SIR-Spheres® (90Y-labelled Resin Microspheres) delivered into tumour-feeding blood vessels
- What this could lead to
- If it works, this could offer a new treatment option for recurrent glioblastoma, a brain cancer with very few effective therapies.
- What could go wrong
- This is a very early pilot study with only 12 participants, so results may not apply broadly. Delivering radiation directly to the brain carries risks of damage to healthy tissue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Austin Hospital
Melbourne, Victoria, 3084, Australia
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