Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
An advanced MRI-based, single-centre investigation of grade 4 gliomas
Query!
Secondary ID [1]
312366
0
nil known
Query!
Universal Trial Number (UTN)
U1111-1301-8117
Query!
Trial acronym
GBM002
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Glioblastoma, Isocitrate dehydrogenase (IDH)-wildtype
334154
0
Query!
Grade 4 Astrocytoma, IDH-mutant
334155
0
Query!
Condition category
Condition code
Cancer
330825
330825
0
0
Query!
Brain
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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).
Query!
Intervention code [1]
328865
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
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.
Query!
Assessment method [1]
338592
0
Spatial correlation between APT abnormality and T1C+ MRI -defined tumour volumes will be evaluated via measurements of DICE similarity co-efficient. Dice similarity coefficients > 0.9 will be considered a strong spatial correlation between APT and T1C+
Query!
Timepoint [1]
338592
0
Preoperative single timepoint
Query!
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.
Query!
Assessment method [2]
339116
0
Spatial correlation between DTI abnormality and T1C+ MRI -defined tumour volumes will be evaluated via measurements of DICE similarity co-efficient. Dice similarity coefficients > 0.9 will be considered a strong spatial correlation between DTI and T1C+
Query!
Timepoint [2]
339116
0
Preoperative single timepoint
Query!
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.
Query!
Assessment method [3]
339117
0
Spatial correlation between MRS metabolic abnormalities and T1C+ MRI -defined tumour volumes will be evaluated via measurements of DICE similarity co-efficient. Dice similarity coefficients > 0.9 will be considered a strong spatial correlation between MRS and T1C+
Query!
Timepoint [3]
339117
0
Preoperative single timepoint
Query!
Secondary outcome [1]
436520
0
Nil
Query!
Assessment method [1]
436520
0
Nil
Query!
Timepoint [1]
436520
0
Nil
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Natural history
Query!
Duration
Cross-sectional
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
30/08/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/05/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
1/05/2025
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
316774
0
University
Query!
Name [1]
316774
0
University of Newcastle
Query!
Address [1]
316774
0
Query!
Country [1]
316774
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Newcastle
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
318991
0
None
Query!
Name [1]
318991
0
Query!
Address [1]
318991
0
Query!
Country [1]
318991
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315542
0
Hunter New England Human Research Ethics Committee
Query!
Ethics committee address [1]
315542
0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Query!
Ethics committee country [1]
315542
0
Australia
Query!
Date submitted for ethics approval [1]
315542
0
01/02/2024
Query!
Approval date [1]
315542
0
16/02/2024
Query!
Ethics approval number [1]
315542
0
2024/ETH00208
Query!
Summary
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
135026
0
Prof Michael Fay
Query!
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
Query!
Country
135026
0
Australia
Query!
Phone
135026
0
+61 2 4921 5944
Query!
Fax
135026
0
Query!
Email
135026
0
[email protected]
Query!
Contact person for public queries
Name
135027
0
Michael Fay
Query!
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
Query!
Country
135027
0
Australia
Query!
Phone
135027
0
+61 2 4921 5944
Query!
Fax
135027
0
Query!
Email
135027
0
[email protected]
Query!
Contact person for scientific queries
Name
135028
0
Michael Fay
Query!
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
Query!
Country
135028
0
Australia
Query!
Phone
135028
0
+61 2 4921 5944
Query!
Fax
135028
0
Query!
Email
135028
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Consistent with our institutional privacy protection policy
Query!
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.
Download to PDF