NCT06572475Recruiting
USPIO Enhanced MR Imaging in CNS Tumours (UMIC)
USPIO Enhanced MR Imaging in CNS Tumours (UMIC) : A Pilot Study of Ferumoxytol (Feraheme ©) as an Imaging Biomarker of Tumour Associated Macrophage (TAM) Infiltration in Vestibular Schwannoma (VS) and Transforming Low Grade Glioma (LGG)
Source: ClinicalTrials.gov · Last updated 27 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- First submitted
- 15 Jun 2024
- Start date
- 26 Apr 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Northern Care Alliance NHS Foundation Trust
- Diseases
- Childhood cancers
- NCT number
- NCT06572475
What you commit to
- Study type: Interventional
- Planned participants: 17
- From 26 Apr 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CNS radiotherapy/ stereotactic radiosurgery (SRS)
Other illness
- Patients with known and documented history of iron overload/haemosiderosis/ haemochromatosis
- Patients with immune or inflammatory conditions e.g. systemic lupus erythematous, rheumatoid arthritis
- Patients with a history of allergic reaction to iron or dextran
- Patients with a history of allergic reaction to gadolinium contrast agents, asthma or renal problems
Lab values
- Patients with an eGFR \< 30ml/min
Other
- Life expectancy less than 1 year
- Females who are pregnant/ breastfeeding
- Patients with absolute (e.g. pacemaker) and relative (anxiety or claustrophobia) contraindications to MR scanning
- Patients who are unable to adequately understand verbal explanations or written information given in English.
Who 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 protocol.
Age in the registry: 16 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Salford Royal Hospital Northern Care Alliance NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.