Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma (NCT07712770) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma
Australia12 participantsStarted 2026-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety - Treatment-related adverse events
Timeframe: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
2
Safety - Severe treatment-related adverse events
Timeframe: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
3
30-day mortality
Timeframe: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Trial details
NCT IDNCT07712770
SponsorOlivia Newton-John Cancer Research Institute
. 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
Exclusion criteria
. 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