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An advanced MRI-based, single-centre investigation of high grade gliomas

An advanced MRI-based, single-centre investigation of grade 4 gliomas

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001014549
Acronym
GBM002
Enrollment
30
Registered
2024-08-21
Start date
2024-08-30
Completion date
2025-05-01
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether advanced MRI scanning techniques can provide more detailed information regarding high-grade brain tumours in patients who have brain cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a grade 4 glioma or astrocytoma (brain tumour) and you are able to undergo an MRI scan. Study details All participants who choose to enrol in this study will be asked to undergo a single MRI scan. This scan is anticipated to take 60 minutes/hours. You will need to have a tracing agents injected as part of this scan (as you would usually). There are no extra blood tests as part of this study but you will be invited to contribute a blood sample for biobanking It is hoped this research will determine whether advanced MRI scanning techniques can identify biomarkers specific to brain tumours, and provide further information about the location and type of brain tumour for cancer patients. If these techniques are successful, the information provided by the MRI scans could assist doctors to determine which treatment options would be most effective for patients with brain cancer.

Interventions

WHO grade 4 gliomas (Glioblastoma IDH-wildtype and Astrocytoma IDH-mutant) are the most lethal types of brain tumours, with a median survival of just 14 months. 30 patients with newly-diagnosed brain cancer with glioblastoma or grade 4 astrocytoma will undergo a single advanced MRI scan before they undergo surgery to remove the tumour (following the routine treatment pathway). The advanced MRI incorporates a number of MRI sequences including the usually acquired (T1, T2, T1 post-contrast and

WHO grade 4 gliomas (Glioblastoma IDH-wildtype and Astrocytoma IDH-mutant) are the most lethal types of brain tumours, with a median survival of just 14 months. 30 patients with newly-diagnosed brain cancer with glioblastoma or grade 4 astrocytoma will undergo a single advanced MRI scan before they undergo surgery to remove the tumour (following the routine treatment pathway). The advanced MRI incorporates a number of MRI sequences including the usually acquired (T1, T2, T1 post-contrast and T2-FLAIR) as well as other specific sequences (Diffusion Tensor imaging [DTI], Magnetic resonance spectroscopy [MRS], amide proton transfer [APT] weighted and perfusion weighted imaging). This imaging protocol will take one hour in total. The scan will be acquired prior to surgery and as per usual practice will involve administration of intravenous gadovist™contrast at usual clinical dose (0.1 mmil/kg body weight).. The exact timing prior to surgery will vary. The MRI scan will be undertaken on the HMRI scanner by a suitably trained senior radiographer experience in brain imaging. The scans will be reviewed by a radiologist and formally reported which will be reviewed by the medical monitor. The scan will be used instead of routinely performed MRI prior to surgery, in addition to collecting additional data using sequences that are not usually implemented clinically. These additional sequences will provide information pertaining to the widespread and subtle changes that occur as a result of the tumour. Participants will be scanned at a single timepoint (preoperatively).

Sponsors

University of Newcastle
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Untreated CNS WHO grade 4, adult-type diffuse glioma (GBM IDH-wildtype, or Astrocytoma IDH-mutant), • Adults aged 18 years or older, • Participants capable of childbearing are using adequate contraception, • Has provided written informed consent

Exclusion criteria

• Patients who are pregnant, lactating / breastfeeding, or expecting pregnancy, • Patients who are severely cognitively impaired, such that they are unable to provide informed consent • Reduced kidney function (determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for estimated Glomerular Filtration Rate (eGFR). An eGFR < 30 mL/min/1.73m2 precludes administration of Gadovist (and therefore excludes them from participation), • A prior resection of the primary lesion or radiotherapy treatment in the brain (i.e only newly diagnosed patients) • Patients who are unable to lie flat for the duration of the MRI scan (of about an hour) • Any contraindication to MRI scanning, including: o Cardiac pacemaker or defibrillator, o Metal fragments in the eye, o Severe claustrophobia, o Any other non-MRI compatible medical device/implant or medical condition.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026