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Trial registered on ANZCTR


Registration number
ACTRN12624001014549
Ethics application status
Approved
Date submitted
19/06/2024
Date registered
21/08/2024
Date last updated
21/08/2024
Date data sharing statement initially provided
21/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An advanced MRI-based, single-centre investigation of high grade gliomas
Scientific title
An advanced MRI-based, single-centre investigation of grade 4 gliomas
Secondary ID [1] 312366 0
nil known
Universal Trial Number (UTN)
U1111-1301-8117
Trial acronym
GBM002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma, Isocitrate dehydrogenase (IDH)-wildtype 334154 0
Grade 4 Astrocytoma, IDH-mutant 334155 0
Condition category
Condition code
Cancer 330825 330825 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Intervention code [1] 328865 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338592 0
Determination of the spatial correlation between APT (Amide proton transfer) and the tumour defined on T1 contrast enhanced MRI; to assess tumour infiltration.
Timepoint [1] 338592 0
Preoperative single timepoint
Primary outcome [2] 339116 0
Determination of the spatial correlation between DTI (diffusion tensor imaging) abnormality and the tumour defined on T1 contrast enhanced (T1C+) MRI; to assess tumour infiltration.
Timepoint [2] 339116 0
Preoperative single timepoint
Primary outcome [3] 339117 0
Determination of the spatial correlation between MRS (MR spectroscopy) derived metabolic maps and the tumour defined on T1 contrast enhanced MRI; to assess tumour infiltration.
Timepoint [3] 339117 0
Preoperative single timepoint
Secondary outcome [1] 436520 0
Nil
Timepoint [1] 436520 0
Nil

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size is typical of hypothesis-driven clinical imaging research. We believe this sample size will cover enough of the heterogeneity to be representative.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316774 0
University
Name [1] 316774 0
University of Newcastle
Country [1] 316774 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 318991 0
None
Name [1] 318991 0
Address [1] 318991 0
Country [1] 318991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315542 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315542 0
Ethics committee country [1] 315542 0
Australia
Date submitted for ethics approval [1] 315542 0
01/02/2024
Approval date [1] 315542 0
16/02/2024
Ethics approval number [1] 315542 0
2024/ETH00208

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135026 0
Prof Michael Fay
Address 135026 0
Mark Hughes Foundation Centre for Brain Cancer Research / Hunter Medical Research Institute, Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305, Australia
Country 135026 0
Australia
Phone 135026 0
+61 2 4921 5944
Fax 135026 0
Email 135026 0
michael.fay@newcastle.edu.au
Contact person for public queries
Name 135027 0
Michael Fay
Address 135027 0
Mark Hughes Foundation Centre for Brain Cancer Research / Hunter Medical Research Institute, Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305, Australia
Country 135027 0
Australia
Phone 135027 0
+61 2 4921 5944
Fax 135027 0
Email 135027 0
michael.fay@newcastle.edu.au
Contact person for scientific queries
Name 135028 0
Michael Fay
Address 135028 0
Mark Hughes Foundation Centre for Brain Cancer Research / Hunter Medical Research Institute, Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305, Australia
Country 135028 0
Australia
Phone 135028 0
+61 2 4921 5944
Fax 135028 0
Email 135028 0
michael.fay@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consistent with our institutional privacy protection policy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.