An Early Phase 1 interventional study of SIR-Spheres® in Recurrent Glioblastoma IDH Wildtype and Recurrent Glioblastoma, sponsored by Olivia Newton-John Cancer Research Institute. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Olivia Newton-John Cancer Research Institute · Early Phase 1, Interventional, and Treatment
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.
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.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 12 is below the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Olivia Newton-John Cancer Research Institute is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate haematologic, renal, hepatic, and coagulation function at screening, defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: 90Y-labelled Resin Microspheres
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.
Time frame: 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
Time frame: 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.
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after the last patient has been enrolled
Overall survival (OS)
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).
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.
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).
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).
Time frame: 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.
Time frame: Assessed up to 6 months after enrolment
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
Time frame: 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
Time frame: 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.
Time frame: 6 months after the last patient has been enrolled
Plan to share: Undecided — Data sharing to occur at publication.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Olivia Newton-John Cancer Research Institute