Clinical trial NCT05500612: MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy
Official title: Magnetic Resonance Imaging of Hypoxia for Radiation Treatment Guidance in Glioblastoma Multiforme (MANGO)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma Multiforme
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: The Brain Cancer Group
First posted: 2022-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Histopathological diagnosis of a high grade glioma / glioblastoma multiforme

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.

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.

Eligibility 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.

Primary outcomes:
measure: Determination of spatial correlation of hypoxic tumour volume between Magnetic resonance imaging (MRI) and [18F]-Fluoromisonidazole (18F-FMISO) MRI
timeFrame: 1 year
Secondary outcomes:
measure: Repeatability of voxel-wise levels of hypoxia in the tumour
timeFrame: 1 year
measure: The predicted patient outcomes of the biologically-adapted Radiotherapy (RT) plan will be compared with the actual patient outcomes
timeFrame: 1 year
measure: Correlation between the percentage of hypoxic tumour volume and clinical outcome
timeFrame: 1 year
measure: Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Caterina Brighi
role: PRINCIPAL_INVESTIGATOR
References: