Actively Recruiting

Phase Not Applicable
Age: 16Years - 100Years
All Genders
NCT06572475

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

Age: 16Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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USPIO Enhanced MR Imaging in CNS Tumours (UMIC) | DecenTrialz