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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
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Scientific title
Magnetic Resonance Imaging of Hypoxia for Radiation Treatment Guidance in Glioblastoma Multiforme (MANGO)
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Secondary ID [1]
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ETH11794
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Universal Trial Number (UTN)
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Trial acronym
MANGO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme
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Condition category
Condition code
Cancer
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Brain
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determination of spatial correlation of hypoxic tumour volume between Magnetic resonance imaging (MRI) and [18F]-Fluoromisonidazole (18F-FMISO) MRI
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Assessment method [1]
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Spatial correlation between hypoxic tumour volume determined with MRI and 18F-FMISO will be evaluated via measurements of Dice similarity coefficient. Dice similarity coefficients > 0.9 will be considered a strong spatial correlation. Quantitative correlation of voxel-wise levels of hypoxia will be evaluated via measurement of the Spearman's/Pearson's correlation coefficient. Correlation coefficients > 0.7 will be considered a strong correlation.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Repeatability of voxel-wise levels of hypoxia in the tumour
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Assessment method [1]
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Repeatability of voxel-wise levels of hypoxia in the tumour will be assessed by measurements of intraclass correlation coefficient (ICC).27 ICC values > 0.9 reflect excellent repeatability, good between 0.75 and 0.9, moderate between 0.5 and 0.75, and poor < 0.5. Additionally, similarity between the hypoxia tumour volume (HTV) defined with the MRI biomarker at the two timepoints will be assessed via calculation of Dice similarity coefficient. Dice similarity coefficients > 0.9 will be considered a strong correlation.
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Timepoint [1]
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1 year
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Secondary outcome [2]
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The predicted patient outcomes of the biologically-adapted Radiotherapy (RT) plan will be compared with the actual patient outcomes
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Assessment method [2]
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The predicted patient outcomes of the biologically-adapted RT plan will be compared with the actual patient outcomes following conventional treatment, by using metrics including tumour control probability (TCP) and toxicity measurement to organs at risks and healthy brain (including equivalent uniform dose). Success for this objective will be achieved if the biologically-adapted RT plans result in improved TCP by at least 10% for all patients over conventional treatment, while toxicity metrics remain similar.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Correlation between the percentage of hypoxic tumour volume and clinical outcome
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Assessment method [3]
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Correlation between the percentage of hypoxic tumour volume and clinical outcome will be evaluated by means of hazard ratio obtained from Cox regression. A hazard ratio > 1 (p<0.05) will indicate that the hypoxic tumour volume increase from 13 weeks post chemoradiation therapy (CRT) and recurrence is associated with worst Overall Survival (OS) and Progression Free Survival (PFS).
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome
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Assessment method [4]
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Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome will be evaluated by means of hazard ration obtained from Cox regression. A hazard ratio > 1 (p<0.05) will indicate that the increase in hypoxic tumour volume during treatment is associated with worse OS.
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Timepoint [4]
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1 year
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/06/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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North Shore Private Hospital - St Leonards
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Brain Cancer Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05500612
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Caterina Brighi
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Shona Silvester
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Address
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Country
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Phone
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+61286271185
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05500612
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