None listed
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility of using a newly available combined PET-MRI platform to identify hypoxic areas in patients with glioblastoma (GBM) to target during surgery. Who it is for? You may be eligible to join this study if you are aged 18 years or above and have suspected high grade glioma for which surgery is planned. Study details All participants in this study will undergo PET/MRI (Positron Emission Tomography / Magnetic Resonance Imaging) at Herston Imaging Research Facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called F-MISO. You will then be required to wait for 2 hours, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported. Fifteen minutes after the start of your scan a qualified Nuclear Medicine Technologist will give you a further injection of a radioactive substance called F-DOPA. The PET camera and MRI will scan your head including your whole brain. The scan time will be approximately 90 minutes and the scan is painless. The experience of the scan itself will be similar to an MRI which you may already have had. Hypoxic areas identified in the PET/MRI will subsequently be targeted during surgery. Key outcomes include feasibility, and comparison of PET/MRI results to biopsies taken during surgery. Demonstrating feasibility of pre-operative combined PET/MRI for glioma would of itself be useful for patients as it reduces the overall number of scans they have to attend in the limited time between presentation and resection.
Interventions
F-DOPA and F-MISO PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) scan will be performed at Herston Imaging Research Facility (HIRF) by a qualified Nuclear Medicine Technologist and Radiographer.
F-MISO 370MBq will be injected into the patient, two hours prior to the scan being performed in order for uptake to occur. 15 minutes after starting image acquisition, FDOPA 150MBq will be injected with the patient in the scanner and scanning will continue for another 75 minutes. Th
F-DOPA and F-MISO PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) scan will be performed at Herston Imaging Research Facility (HIRF) by a qualified Nuclear Medicine Technologist and Radiographer. F-MISO 370MBq will be injected into the patient, two hours prior to the scan being performed in order for uptake to occur. 15 minutes after starting image acquisition, FDOPA 150MBq will be injected with the patient in the scanner and scanning will continue for another 75 minutes. The total scan time will be 90 minutes and the total time participants will be required at HIRF will be 3.5 Hours. The imaging session will be performed within five days prior to the planned Neurosurgery. The images obtained will be exported to neuronavigation software for use in theatre to allow for biopsy to be performed on targeted areas. Participants will be separately consented for maximal safe resection by their nominated Neurosurgeon for their suspected high grade glioma (glioblastoma) with tissue biobanking. This is part of the current standard consent process and will be performed by the surgical team not the investigator consenting the patient to the current study. During the surgical resection tissue will be collected by trained and approved QIMR Berghofer laboratory personnel. The de-identified samples will be clearly labeled as research material and transported in a double-container as per safety regulations on ice to the laboratory.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or older Has provided written, informed consent for participation in this trial History, clinical findings and imaging including MRI considered highly suspicious for high grade glioma Planned for debulking surgery by neurosurgery Willing to consent or already consented to “The expression of developmental genes in tumours and blood disorders” Tissue Banking project. Considered clinically appropriate to undergo preoperative functional imaging and MRI scans at Herston Imaging Research Facility (HIRF) ECOG performance status 2 or less
Exclusion criteria
Only surgical procedure planned is open or needle biopsy (<50% of tumour volume) Women who are pregnant or lactating Previous surgery or radiotherapy to brain for any indication Previous chemotherapy for any indication Prior diagnosis of cancer (excluding successfully treated basal cell or squamous cell carcinoma of the skin) Any clinical or radiologic evidence of metastatic malignancy
Outcome results
None listed