Actively Recruiting
USPIO Enhanced MR Imaging in CNS Tumours (UMIC)
Led by Northern Care Alliance NHS Foundation Trust · Updated on 2024-08-27
17
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The immune response or inflammation is known to be a key driver of progression and growth in many solid tumours. Inflammatory cells called macrophages are present in high numbers in many brain tumours and these tumour associated macrophages or TAM are thought to have prognosis and treatment implications in these tumours. A key question, however, is how this inflammation or TAM abundance can be detected, measured and monitored in the clinic. A clinically applicable imaging test that can directly and accurately measure tumour macrophage content would be of considerable value and one technique that may provide this is USPIO enhanced magnetic resonance imaging (MRI). Following intravenous injection, USPIO or ultrasmall superparamagnetic iron oxide nanoparticles, circulate in the bloodstream before being taken up by inflammatory cells/macrophages in tumour tissue, wherein they can be detected by MRI. This pilot study is to evaluate if a commercially available USPIO preparation called ferumoxytol (Feraheme ©) can accurately quantify macrophage abundance in brain tumours, with an exploratory focus on vestibular schwannoma (VS) and suspected transforming low-grade glioma (LGG). Patients with both non-growing (static) and growing VS, and patients with suspected transforming LGG will undergo dedicated MRI sequences before, immediately after (\< 2 hours) and at both 24 and 48hrs after ferumoxytol administration. In patients undergoing surgery, acquired imaging will be compared with resected tumour tissue so that markers of inflammation can be compared with USPIO uptake. Through advanced laboratory methods this study will seek to establish within resected VS and LGG specimens: the cellular destination/s of USPIO uptake; the nature of the inflammatory and/or tumour cells containing the USPIO; and the relationship between USPIO uptake and tumour blood vessel permeability or leakiness.
CONDITIONS
Official Title
USPIO Enhanced MR Imaging in CNS Tumours (UMIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 16 years old
- Have a CNS tumour suspected to be vestibular schwannoma or low-grade glioma
- Be able to lie still comfortably for up to 1 hour
- Treating clinician believes the patient can complete the research imaging protocol successfully
You will not qualify if you...
- Life expectancy less than 1 year
- Previous central nervous system radiotherapy or stereotactic radiosurgery
- Females who are pregnant or breastfeeding
- Patients with eGFR less than 30 ml/min
- History of iron overload, haemosiderosis, or haemochromatosis
- Immune or inflammatory conditions such as systemic lupus erythematous or rheumatoid arthritis
- Absolute contraindications to MRI such as pacemaker
- Relative contraindications to MRI such as anxiety or claustrophobia
- History of allergic reaction to iron, dextran, gadolinium contrast agents, asthma, or renal problems
- Inability to understand verbal or written information in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Salford Royal Hospital Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, United Kingdom, M6 6HD
Actively Recruiting
Research Team
D
Daniel Lewis, PhD MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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