USPIO Enhanced MR Imaging in CNS Tumours (UMIC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-100
SponsorNorthern Care Alliance NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be at least 16 years old
Have a CNS tumour suspected to be one of the defined histological types (vestibular scwhannoma or low grade glioma)
Be able to lie still for up to 1 hour comfortably
Opinion of the treating clinician is that the patient will be able to successfully complete the research imaging protocol.
Disqualifiers
Life expectancy less than 1 year
Previous CNS radiotherapy/ stereotactic radiosurgery (SRS)
Females who are pregnant/ breastfeeding
Patients with an eGFR < 30ml/min
Trial design
Design model
Single group
Treatments tested in this trial
USPIO enhanced MRI
Diagnostic testFerumoxytol (Feraheme©, AMAG pharmaceuticals, US) enhanced MRI
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: Trial arm 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Establish in a cohort of surgically resected sporadic VS if the enhancement pattern of delayed (24-48 hr) USPIO uptake correlates with tissue markers of TAM density and tissue microvascular markers.
Use correlation tests to establish the relationship between delayed (24-48 hr) USPIO related MRI signal intensity changes and tissue markers of TAM density and microvascular markers.
Time frame
Three years2
Establish the relationship between enhancement patterns following GBCA administration and the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours.
Differences in the enhancement pattern between post GBCA T1W images and the delayed (24-48hr) ferumoxytol enhanced T1W images will be compared through visual inspection and use of the structural similarity index
Time frame
Three years3
Evaluate the association between microvascular parameters derived from dynamic contrast enhanced (DCE) MRI) and the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours.
Use voxelwise correlation tests and ROI analysis to establish the relationship between microvascular parameters derived from dynamic contrast enhanced (DCE) MRI) and USPIO related signal intensity changes at early (\<2hr) and delayed (24-48 hr) imaging timepoints in these tumours.
Time frame
Three years4
Establish in VS the relationship between the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours with tumour size and tumour growth status (non-growing or static vs growing).
Evaluate using appropriate parametric and non-parametric statistical tests if there are differences between non-growing and growing VS in USPIO related signal intensity changes on acquired T1, T2 and T2\* weighted imaging at early (\<2hr) and delayed (24-48 hr) imaging timepoints. Evaluate using correlation and regression analyses if there is a relationship between tumour size and USPIO related signal intensity changes on acquired T1, T2 and T2\* weighted imaging at early (\<2hr) and delayed (24-48 hr) imaging timepoints.
Time frame
Three yearsSponsors and contacts
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Source ClinicalTrials.gov