USPIO Enhanced MR Imaging in CNS Tumours (UMIC)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06572475
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northern Care Alliance NHS Foundation Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Coope, PhD FRCS(SN)
Principal Investigator Affiliation Northern Care Alliance NHS Foundation Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Vestibular Schwannoma, Glioma, Astrocytic
Arms & Interventions

Arms

Experimental: Trial arm 1

Group A: Patients with sporadic VS undergoing radiological surveillance (n=12). The sample will include growing tumours (n=6) that are being considered for surgical resection, and non-growing/static tumours (n=6) that are being considered for either further radiological surveillance or surgery. Group B: Patients with suspected transforming low-grade glioma (n=5). Patients in this cohort will have a proven or suspected diagnosis of low-grade glioma (LGG) but with features on routine clinical imaging suggestive of malignant transformation to either grade III (anaplastic) or grade IV glioma. Patients with suspected transforming LGG who are listed to undergo surgical resection will be enrolled into the study so that acquired imaging can be compared with tissue datasets.

Interventions

Diagnostic Test: - USPIO enhanced MRI

Ferumoxytol (Feraheme©, AMAG pharmaceuticals, US) enhanced MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Salford, Greater Manchester, United Kingdom

Status

Recruiting

Address

Salford Royal Hospital Northern Care Alliance NHS Foundation Trust

Salford, Greater Manchester, M6 6HD

Site Contact

Hannah Howlett

[email protected]

+441612067050

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