DEtection of Cellular Inflammation With FERumoxytol in the HEART (DECIFER)

May 2, 2017 updated by: University of Edinburgh

To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium of patients with:

i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ferumoxytol is a 'smart' magnetic resonance contrast agent consisting of ultrasmall superparamagnetic particles of iron oxide (USPIOs) that are taken up by macrophages. Concentration of USPIOs within macrophages changes the tissue relaxation properties and this can be detected by magnetic resonance imaging using R2* maps. In a recent early proof-of-concept study, we demonstrated that macrophages could be detected with USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators therefore wish to establish whether USPIOs can be used to identify cellular inflammation within the myocardium in three distinct clinical conditions that currently lack a non-invasive diagnostic imaging test: cardiac allograft rejection, viral myocarditis and cardiac sarcoidosis. If successful, this would not only provide a useful diagnostic test but would also be a method of monitoring disease progression or response to therapy.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • London, United Kingdom
        • Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. One of the four conditions below:

    • Patients having undergone cardiac transplant
    • Patients diagnosed clinically with myocarditis of any aetiology (eg viral, septic, post chemotherapeutic etc)
    • Patients clinically diagnosed with cardiac sarcoidosis
    • Healthy volunteers
  2. Age > 18 years.

Exclusion Criteria:

  1. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire
  2. Patients refusing or unable to give informed consent
  3. Renal failure (estimated glomerular filtration rate <30 mL/min)
  4. Polycythemia
  5. Contraindication to ferumoxytol (previous allergic drug reaction, any immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis, history of severe asthma, eczema or other atopic allergy)), evidence of known iron overload, hemochromatosis, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency.
  6. Known allergy to dextran- or iron-containing compounds.
  7. Diagnosis of myocardial infarction within 1 month.
  8. Pregnancy or Breast-feeding.
  9. Women of child bearing age not ensuring reliable methods of contraception. Female participants of child bearing age will be asked if they are ensuring reliable methods of contraception prior to each administration of USPIO and MRI scan. If use of reliable contraception cannot be confirmed, the participant will be withdrawn.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Myocarditis
Drug: Ferumoxytol
Infusion following between paired MRI scans
Active Comparator: Cardiac sarcoid
Drug: Ferumoxytol
Infusion following between paired MRI scans
Active Comparator: Cardiac Transplant
Drug: Ferumoxytol
Infusion following between paired MRI scans
Placebo Comparator: Healthy Volunteers
Drug: Ferumoxytol
Infusion following between paired MRI scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Myocardial Cellular Inflammation.
Time Frame: 1 year
Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of R2* values with circulating inflammatory markers
Time Frame: 1 year
Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) .
1 year
Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)
Time Frame: 1 year
Does treatment or recovery from these inflammatory myocardial conditions reduce or halt uptake of USPIOs as assessed by reduction in R2* values.
1 year
Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement)
Time Frame: 1 year
Do patients with higher R2* values have worse outcomes assessed by deterioration in ejection fraction or increase in late gadolinium enhancement.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Royal Brompton & Harefield NHS Foundation Trust
Royal Infirmary of Edinburgh
Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Colin Stirrat, MBChB, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-002336-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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