None listed
Conditions
Brief summary
This is a main, prospective, interventional study performing specific MRI brain sequences pre and post intravenous administration of an iron oxide compound called ferumoxytol in patients with a preliminary radiological diagnosis of primary grade 3 or 4 astrocytoma, and patients with a preliminary radiological diagnosis of a brain tumour metastasis. The study aims to determine how ferumoxytol imaging compares to that using the standard MRI contrast agent (gadolinium), and if ferumoxytol can be used to identify patients with a high content of tumour associated immune cells (macrophages) in their tumour. If so this could predict those more likely to have a poorer outcome at diagnosis. An infusion of ferumoxytol will be administered intravenous over a 30 minute period according to the protocol dosing regimen, followed by MRI scanning 24 hours post ferumoxytol administration. The ferumoxytol -MRI image will be compared with the standard MRI image to determine how the imaging compares. Tumours with a high and low content of macrophages will be compared to determine if ferumoxytol imaging is related to the macrophage content in the tumour.
Interventions
This is a main, prospective, interventional study performing specific MRI brain sequence pre and post intravenous administration of an iron oxide compound (ferumoxytol) used here off label as an MRI contrast agent in 40 patients with a preliminary radiological diagnosis of primary stage 3 or 4 astrocytoma, and 40 patients with a preliminary radiological diagnosis of a secondary tumour (brain metastasis from the colon, breast, lung and melanoma). Following preliminary diagnosis of primary stage
This is a main, prospective, interventional study performing specific MRI brain sequence pre and post intravenous administration of an iron oxide compound (ferumoxytol) used here off label as an MRI contrast agent in 40 patients with a preliminary radiological diagnosis of primary stage 3 or 4 astrocytoma, and 40 patients with a preliminary radiological diagnosis of a secondary tumour (brain metastasis from the colon, breast, lung and melanoma). Following preliminary diagnosis of primary stage 3 or 4 astrocytoma, or a secondary tumour using gadolinium contrast MRI, an intravenous infusion of ferumoxytol (2.6 mg/kg diluted in 100 ml of normal saline and infused over a 30 minutes period) will be administered by a radiologist, radiology registrar, or surgical registrar, followed by MRI scanning 24 hours later. The MRI scan will take approximately 40 minutes to complete. Ferumoxytol MRI will occur between 12 hours and 5 days following the gadolinium MRI. The fermumoxytol infusion will be supervised, and the MRI sequences checked for the superparamagnetic properties of iron. As part of the participants standard of care the tumour will be removed and the tumour tissue excised will be measured for iron using special staining to monitor adherence to the intervention.
Sponsors
Tania Slatter
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with an imaging diagnosis based on the baseline diagnostic MRI scan (gadolinium contrast) of primary stage 3 or 4 astrocytoma, or brain tumour metastasis. 2. No steroid treatment that has been administered to the patients between the time 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 preparations or other medication allergies. 4. Patients who have haemochromatosis or known clinically significant liver function abnormalities. 5. The initial diagnostic MRI demonstrates intracranial haemorrhage, calcification or other susceptibility blooming artifacts.
Outcome results
None listed