None listed
Conditions
Brief summary
This is a pilot interventional study to investigate using ferumoxytol as a contrast agent for imaging the aggressive primary brain tumour (glioblastoma). The study is testing using a new type of brain scan that uses extremely small iron particles (ferumoxytol) that then become visible in the brain when imaged using MRI. This study will determine if ferumoxytol is safe to use in glioblastoma patients, identify the best time to image brain tumours once ferumoxytol is administered, and if ferumoxytol does provide suitable brain tumour imaging by comparing the imaging to that obtained using standard imaging (with gadolinium as the contrast agent). Participants will receive a 2.6mg/kg total dose of ferumoxytol diluted in 100ml of normal and infused intravenously for 30minutes. Patients receive the infusion as an inpatient in the neurosurgical ward. At different time points following ferumoxytol infusion patients receive a MRI scan. We hypothesise that ferumoxtyol MRI will be safe, well tolerated, and adequate for imaging glioblastomas when compared with gadolinium MRI.
Interventions
The participants will receive an one-off intravenous iron infusion (the iron oxide compound ferumoxytol, 2.6mg/kg of Feraheme™ diluted in 100 ml of normal saline by a radiologist, radiology registrar or surgical registrar, and administered over 30 minutes. At 18, 24, and 30 hours post ferumoxytol infusion participants will receive an MRI to determine the optimal timing to detect the best brain tumour images. Each MRI scan is approximately 40 minutes. Once the tumour is excised it will be checked
The participants will receive an one-off intravenous iron infusion (the iron oxide compound ferumoxytol, 2.6mg/kg of Feraheme™ diluted in 100 ml of normal saline by a radiologist, radiology registrar or surgical registrar, and administered over 30 minutes. At 18, 24, and 30 hours post ferumoxytol infusion participants will receive an MRI to determine the optimal timing to detect the best brain tumour images. Each MRI scan is approximately 40 minutes. Once the tumour is excised it will be checked for iron using special stains for iron.
Sponsors
Tania Slatter
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 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with an imaging diagnosis of primary glioblastoma 2. No chemotherapy or other treatments (such as steroids) have been administered to the patients between the rime of the baseline diagnostic scan and the ferumoxytol infusion.
Exclusion criteria
1. Patients who are younger than 18 years old. 2. Patients who are pregnant or breast feeding. 3. Patients who have known allergy to iron preparation or other medication allergy. 4. Patients who have haemochromatosis or known clinically significant liver function abnormality. 5. The initial diagnostic MRI demonstrates intracranial haemorrhage, calcification or other susceptibility blooming artifacts.
Outcome results
None listed