DEtection of Cellular Inflammation With FERumoxytol in the HEART

Healthy Volunteers Clinical Trial

— DECIFER  

Official title:

DEtection of Cellular Inflammation With FERumoxytol in the HEART

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319278
• Other study ID #: 2013-002336-24
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 3, 2014
• Last updated: May 2, 2017
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: May 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Sarcoid
• Cardiac Transplant
• Healthy Volunteers
• Inflammation
• Myocarditis

Intervention

Drug:
• Ferumoxytol
Infusion following between paired MRI scans

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Royal Brompton Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
University of Edinburgh	Golden Jubilee National Hospital, Royal Brompton & Harefield NHS Foundation Trust, Royal Infirmary of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Myocardial Cellular Inflammation.	Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.	1 year
Secondary	Correlation of R2* values with circulating inflammatory markers	Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) .	1 year
Secondary	Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)	Does treatment or recovery from these inflammatory myocardial conditions reduce or halt uptake of USPIOs as assessed by reduction in R2* values.	1 year
Secondary	Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement)	Do patients with higher R2* values have worse outcomes assessed by deterioration in ejection fraction or increase in late gadolinium enhancement.	1 year