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Trial Title:
MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy
NCT ID:
NCT05500612
Condition:
Glioblastoma Multiforme
Conditions: Official terms:
Glioblastoma
Hypoxia
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
The ability to image tumour hypoxia at diagnosis and prior to radiotherapy is extremely
important to appropriately adapt radiotherapy plans such that to selectively deliver
higher doses of radiation to those more aggressive tumour subregions, thereby improving
the chances to achieve better local tumour control. Preoperative imaging of tumour
hypoxia also offers the opportunity for 'supra-marginal resections' in surgical planning
beyond current neurosurgical standard of care. Additionally, accurately identifying
regions of tumour hypoxia harbouring tumour progression at follow up is fundamental in
patient follow-up, allowing multidisciplinary teams to more confidently intervene at an
earlier stage of tumour recurrence and personalise therapy tailored to the tumour's
response to treatment. Routine imaging of tumour hypoxia is currently challenging, as it
requires [18F]-Fluoromisonidazole (18F-FMISO PET) imaging, which is not available in the
majority of clinical centres. Today, the availability of accelerated quantitative MRI
sequences on clinical MRI systems could enable quantification of tumour hypoxia without
putting an unfeasible burden on patients' scan sessions. The next frontier in
radiotherapy treatment will use these techniques to identify hypoxic tumour tissues and
personalise treatments to the patient's unique tumour biology, maximising the probability
of tumour control.
This clinical study will acquire additional images of brain cancer patients. The images
will not change the patient's treatment. This study is designed to evaluate the role of
oxygen enhanced (OE) MRI and 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.
Criteria for eligibility:
Study pop:
Histopathological diagnosis of a high grade glioma / glioblastoma multiforme
Sampling method:
Probability Sample
Criteria:
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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
North Shore Private Hospital
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Contact:
Last name:
Shona Silvester
Phone:
+61 2 8627 1185
Email:
shona.silvester@sydney.edu.au
Facility:
Name:
Royal North Shore Hospital
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Contact:
Last name:
Shona Silvester
Phone:
+61 2 8627 1185
Email:
shona.silvester@sydney.edu.au
Start date:
June 2024
Completion date:
December 2025
Lead sponsor:
Agency:
University of Sydney
Agency class:
Other
Collaborator:
Agency:
The Brain Cancer Group
Agency class:
Other
Source:
University of Sydney
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05500612
