Using special MRI to detect inflammation in brain tumors
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)
This study is testing a special MRI technique that uses a contrast agent to see if it can help doctors spot inflammation in brain tumors like vestibular schwannomas and gliomas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 16 Years to 100 Years |
| Sex | All |
| Sponsor | Northern Care Alliance NHS Foundation Trust Academic / other |
| Locations | 1 site (Salford, Greater Manchester) |
| Trial ID | NCT06572475 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of ultrasmall superparamagnetic iron oxide (USPIO) enhanced magnetic resonance imaging (MRI) to measure the abundance of tumor-associated macrophages in central nervous system tumors, specifically vestibular schwannomas and gliomas. By injecting USPIO into patients, the imaging technique aims to visualize and quantify the inflammatory response within the tumor, which may have implications for prognosis and treatment. The study focuses on determining the feasibility and effectiveness of this imaging method in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 and older with a suspected CNS tumor of the specified types who can remain still during the imaging process.
Not a fit: Patients with a life expectancy of less than one year, previous CNS radiotherapy, or certain medical conditions that contraindicate MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to assess tumor inflammation, potentially guiding treatment decisions for patients with brain tumors.
How similar studies have performed: While the use of USPIO in MRI is a novel approach, similar imaging techniques have shown promise in other studies for assessing inflammation in tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Patients with immune or inflammatory conditions e.g. systemic lupus erythematous, rheumatoid arthritis * Patients with absolute (e.g. pacemaker) and relative (anxiety or claustrophobia) contraindications to MR scanning * 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 * Patients who are unable to adequately understand verbal explanations or written information given in English.
Where this trial is running
Salford, Greater Manchester
- Salford Royal Hospital Northern Care Alliance NHS Foundation Trust — Salford, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David Coope, PhD FRCS(SN) — Northern Care Alliance NHS Foundation Trust
- Study coordinator: Daniel Lewis, PhD MBBS
- Email: daniel.lewis-3@manchester.ac.uk
- Phone: +441612067050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.