Vestibular SchwannomaUMICNCT06572475
USPIO Enhanced MR Imaging in CNS Tumours (UMIC)
A study testing USPIO enhanced MRI in people with Vestibular Schwannoma and Glioma, Astrocytic, run by Northern Care Alliance NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Vestibular Schwannoma, Glioma, Astrocytic
- What is being tested?
- USPIO enhanced MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Salford Royal Hospital Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, M6 6HD
Hannah Howlett, RDResearch@nca.nhs.uk
About this study
Official title: 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)
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
- Vestibular Schwannoma, Glioma, Astrocytic
- Being tested
- USPIO enhanced MRI
- Medical subject headings
- Neuroma, Acoustic, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USPIO enhanced MRIDiagnostic test
Ferumoxytol (Feraheme©, AMAG pharmaceuticals, US) enhanced MRI
| Study group | Role | What they receive |
|---|---|---|
| Trial arm 1 | Experimental | 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. Receives: Diagnostic Test: USPIO enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish in a cohort of surgically resected sporadic VS if the enhancement pattern of delayed (24-48 hr) USPIO uptake correlates with tissue markers of TAM density and tissue microvascular markers.
Use correlation tests to establish the relationship between delayed (24-48 hr) USPIO related MRI signal intensity changes and tissue markers of TAM density and microvascular markers.
Measured: Three years
Establish the relationship between enhancement patterns following GBCA administration and the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours.
Differences in the enhancement pattern between post GBCA T1W images and the delayed (24-48hr) ferumoxytol enhanced T1W images will be compared through visual inspection and use of the structural similarity index
Measured: Three years
Evaluate the association between microvascular parameters derived from dynamic contrast enhanced (DCE) MRI) and the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours.
Use voxelwise correlation tests and ROI analysis to establish the relationship between microvascular parameters derived from dynamic contrast enhanced (DCE) MRI) and USPIO related signal intensity changes at early (<2hr) and delayed (24-48 hr) imaging timepoints in these tumours.
Measured: Three years
Establish in VS the relationship between the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours with tumour size and tumour growth status (non-growing or static vs growing).
Evaluate using appropriate parametric and non-parametric statistical tests if there are differences between non-growing and growing VS in USPIO related signal intensity changes on acquired T1, T2 and T2* weighted imaging at early (<2hr) and delayed (24-48 hr) imaging timepoints. Evaluate using correlation and regression analyses if there is a relationship between tumour size and USPIO related signal intensity changes on acquired T1, T2 and T2* weighted imaging at early (<2hr) and delayed (24-48 hr) imaging timepoints.
Measured: Three years
Establish within resected VS and transforming low-grade glioma specimens the cellular destination/s of USPIO internalisation and the in vivo relationship between BBB disruption and USPIO extravasation.
Immunohistochemistry (IHC)/ immunofluorescence will be used on both formalin fixed paraffin embedded (FFPE) and frozen tissue samples to map the uptake of USPIO within immune and non-immune cell populations.
Measured: Three years
Establish if the enhancement pattern of delayed (24-48 hr) USPIO uptake correlates with loco-regional tissue markers of immune cell infiltration and malignant transformation within imaged transforming low grade glioma.
Evaluate using appropriate parametric and non-parametric statistical tests if there are differences in USPIO related signal intensity changes and immune cell infiltration within regions of histologically proven transformation when compared to non-transformed areas.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start26 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Care Alliance NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Coope, PhD FRCS(SN), Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572475
- Sponsor's protocol ID
- 22NEURO06-S
- Acronym
- UMIC
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breese J, Lloyd W, Fothergill A, Djoukhadar I, Tyler A, Bullock E, Cloran K, Li K, Zhu X, Alfaifi B, Sereno T, Naveen Golchha P, McMahon A, Karabatsou K, D'Urso P, Maye H, Bailey M, Hannan C, King AT, Jackson A, Hinz R, Lewis D, Coope D. USPIO enhanced MR imaging in CNS tumors (UMIC): a study protocol. Nanomedicine (Lond). 2026 Jun;21(12):1713-1721. doi: 10.1080/17435889.2026.2681555. Epub 2026 Jun 10.
PubMed 42267547
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06572475
- Acronym / sponsor ID
- UMIC / 22NEURO06-S
- Conditions
- Vestibular Schwannoma, Glioma, Astrocytic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Northern Care Alliance NHS Foundation TrustUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial arm 1 | Experimental | Diagnostic Test: USPIO enhanced MRIGroup 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USPIO enhanced MRIFerumoxytol (Feraheme©, AMAG pharmaceuticals, US) enhanced MRI | Diagnostic test | Trial arm 1 |
Primary outcome
Establish in a cohort of surgically resected sporadic VS if the enhancement pattern of delayed (24-48 hr) USPIO uptake correlates with tissue markers of TAM density and tissue microvascular markers.
Time frame: Three years
Use correlation tests to establish the relationship between delayed (24-48 hr) USPIO related MRI signal intensity changes and tissue markers of TAM density and microvascular markers.
Establish the relationship between enhancement patterns following GBCA administration and the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours.
Time frame: Three years
Differences in the enhancement pattern between post GBCA T1W images and the delayed (24-48hr) ferumoxytol enhanced T1W images will be compared through visual inspection and use of the structural similarity index
Evaluate the association between microvascular parameters derived from dynamic contrast enhanced (DCE) MRI) and the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours.
Time frame: Three years
Use voxelwise correlation tests and ROI analysis to establish the relationship between microvascular parameters derived from dynamic contrast enhanced (DCE) MRI) and USPIO related signal intensity changes at early (<2hr) and delayed (24-48 hr) imaging timepoints in these tumours.
Establish in VS the relationship between the volume, pattern and intensity of early (<2hr) and delayed (24-48 hr) USPIO imaging in these tumours with tumour size and tumour growth status (non-growing or static vs growing).
Time frame: Three years
Evaluate using appropriate parametric and non-parametric statistical tests if there are differences between non-growing and growing VS in USPIO related signal intensity changes on acquired T1, T2 and T2* weighted imaging at early (<2hr) and delayed (24-48 hr) imaging timepoints. Evaluate using correlation and regression analyses if there is a relationship between tumour size and USPIO related signal intensity changes on acquired T1, T2 and T2* weighted imaging at early (<2hr) and delayed (24-48 hr) imaging timepoints.
Establish within resected VS and transforming low-grade glioma specimens the cellular destination/s of USPIO internalisation and the in vivo relationship between BBB disruption and USPIO extravasation.
Time frame: Three years
Immunohistochemistry (IHC)/ immunofluorescence will be used on both formalin fixed paraffin embedded (FFPE) and frozen tissue samples to map the uptake of USPIO within immune and non-immune cell populations.
Establish if the enhancement pattern of delayed (24-48 hr) USPIO uptake correlates with loco-regional tissue markers of immune cell infiltration and malignant transformation within imaged transforming low grade glioma.
Time frame: Three years
Evaluate using appropriate parametric and non-parametric statistical tests if there are differences in USPIO related signal intensity changes and immune cell infiltration within regions of histologically proven transformation when compared to non-transformed areas.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 42267547Breese J, Lloyd W, Fothergill A, Djoukhadar I, Tyler A, Bullock E, Cloran K, Li K, Zhu X, Alfaifi B, Sereno T, Naveen Golchha P, McMahon A, Karabatsou K, D'Urso P, Maye H, Bailey M, Hannan C, King AT, Jackson A, Hinz R, Lewis D, Coope D. USPIO enhanced MR imaging in CNS tumors (UMIC): a study protocol. Nanomedicine (Lond). 2026 Jun;21(12):1713-1721. doi: 10.1080/17435889.2026.2681555. Epub 2026 Jun 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Coope, PhD FRCS(SN) principal investigator
Northern Care Alliance NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USPIO enhanced MRI in people with Vestibular Schwannoma and Glioma, Astrocytic, run by Northern Care Alliance NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lewis, PhD MBBS (+441612067050, daniel.lewis-3@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish in a cohort of surgically resected sporadic VS if the enhancement pattern of delayed (24-48 hr) USPIO uptake correlates with tissue markers of TAM density and tissue microvascular markers. (time frame: Three years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.