At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- USPIO enhanced MRI (diagnostic test)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- USPIO enhanced MRI — diagnostic test: Ferumoxytol (Feraheme©, AMAG pharmaceuticals, US) enhanced MRI
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years to 100 Years
- Who
- All
- Number of participants
- 17
- Started
- 2024-04-26
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for vestibular schwannoma
- • NA - 17 participants
- • The immune response or inflammation is known to be a key driver of progression and growth in many solid tumours
Who can take part?
- • Ages 16 Years to 100 Years
- • Diagnosed with vestibular schwannoma
Where?
- • Salford - Salford Royal Hospital Northern Care Alliance NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 100 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
Who cannot take part
- ✗Life expectancy less than 1 year
- ✗Previous CNS radiotherapy/ stereotactic radiosurgery (SRS)
- ✗Females who are pregnant/ breastfeeding
- ✗Patients with an eGFR \< 30ml/min
- ✗Patients with known and documented history of iron overload/haemosiderosis/ haemochromatosis
See the full criteria
Where Is This Study? (1 UK site)
Salford Royal Hospital Northern Care Alliance NHS Foundation Trust
Salford M6 6HD, United Kingdom
How to Get in Touch
Daniel Lewis, PhD MBBS
Sponsor contactCONTACT