Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma
- Sponsor
- Olivia Newton-John Cancer Research Institute
- Study ID
- NCT07712770
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Recurrent Glioblastoma
- Recurrent Glioblastoma IDH Wildtype
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SIR-Spheres® — DEVICESingle administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated
Study Details
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.
Key Dates
- First listed
- Jul 17, 2026
- Start date
- Oct 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Nov 30, 2028
- Completion
- Nov 30, 2028
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: InterventionSIR-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.
Primary Outcome Measure
Safety - Treatment-related adverse events [ Time Frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration. ]
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