Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05500612




Registration number
NCT05500612
Ethics application status
Date submitted
9/08/2022
Date registered
15/08/2022
Date last updated
6/06/2024

Titles & IDs
Public title
MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy
Scientific title
Magnetic Resonance Imaging of Hypoxia for Radiation Treatment Guidance in Glioblastoma Multiforme (MANGO)
Secondary ID [1] 0 0
ETH11794
Universal Trial Number (UTN)
Trial acronym
MANGO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determination of spatial correlation of hypoxic tumour volume between Magnetic resonance imaging (MRI) and [18F]-Fluoromisonidazole (18F-FMISO) MRI
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Repeatability of voxel-wise levels of hypoxia in the tumour
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
The predicted patient outcomes of the biologically-adapted Radiotherapy (RT) plan will be compared with the actual patient outcomes
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Correlation between the percentage of hypoxic tumour volume and clinical outcome
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome
Timepoint [4] 0 0
1 year

Eligibility
Key inclusion criteria
- Suspected high-grade glioma (HGG) / glioblastoma multiforme (WHO grade IV) at initial
radiological examination

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2

- Available for scanning on two separate days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women lactating, pregnant or of childbearing potential who are not willing to avoid
pregnancy during the study

- Patients with a history of severe renal disease(s) (eGFR <20) that cannot tolerate
gadolinium chelate contrast agents.

- Geographically remote patients unable to agree to imaging schedule

- Patients who have received anti - vascular endothelial growth factor (anti-VEGF)
monoclonal antibody therapy the 3 months prior to recruitment

- Patients with a history of psychological illness or condition such as to interfere
with the patient's ability to understand the requirements of the study.

- Patients with significant cardiac or pulmonary disease including cardiac arrythmias or
Chronic Obstructive Pulmonary Disease (COPD) that are unable to tolerate high flow O2
for oxygen contrast.

- Patients taking carbonic anhydrase inhibitors (Acetazolamide)

- History of glaucoma

- Any implant, foreign body, 3 Tesla (3T) MRI incompatible device, or other
contraindication to MRI imaging.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Brain Cancer Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to evaluate the role of Oxygen Enhanced (OE) Magnetic resonance
imaging (MRI) and Blood Oxygenation Level Dependent (BOLD) MRI in detecting regions of
hypoxic tumour and to evaluate their use as imaging methods to selectively deliver targeted
radiotherapy to regions of aggressive disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05500612
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Caterina Brighi
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shona Silvester
Address 0 0
Country 0 0
Phone 0 0
+61286271185
Fax 0 0
Email 0 0
shona.silvester@sydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05500612