MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy

NCT05500612 | Recruiting

• 1 other identifier: ETH11794
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Determination of spatial correlation of hypoxic tumour volume between Magnetic resonance imaging (MRI) and [18F]-Fluoromisonidazole (18F-FMISO) MRI

  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.

  1 year

Secondary Outcomes (4)

• Repeatability of voxel-wise levels of hypoxia in the tumour

  1 year

• The predicted patient outcomes of the biologically-adapted Radiotherapy (RT) plan will be compared with the actual patient outcomes

  1 year

• Correlation between the percentage of hypoxic tumour volume and clinical outcome

  1 year

• Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Histopathological diagnosis of a high grade glioma / glioblastoma multiforme

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• The Brain Cancer Group: collaborator

Study Sites (2)

North Shore Private Hospital

St Leonards, New South Wales, 2065, Australia

NOT YET RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Caterina Brighi

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shona Silvester

CONTACT

+61286271185; shona.silvester@sydney.edu.au

David Waddington

CONTACT

david.waddington@sydney.edu.au

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 15, 2022
• Study Start: August 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After study completion.
• Access Criteria: Data stored at the university: In order to download / decompress the stored, de-identified data, participating researchers will agree to the terms of use for the data, including that the data are not to be published or otherwise redistributed without the express consent of the original investigator(s). Data stored at an external repository: de-identified study data may be provided to an external research data repository, archive or register so that it may be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.

Locations

AU (2)