PET/MR Imaging In Patients With Cardiac Amyloidosis

Cardiac Amyloidosis Clinical Trial

Official title:

Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Amyloidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626584
• Other study ID #: AC17011
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: August 2018
• Source: University of Edinburgh
• Contact: Nicholas B Spath
• Phone: 0131 242 6515
• Email: nick.spath[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac amyloidosis, a condition which causes thickening of heart muscle due to abnormal protein deposits, is of particular interest. There are different forms of this condition and at present samples of tissue need to be taken and analysed in order to assess these accurately, which carries risks.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. The investigators will use a PET tracer which is widely used in cardiac imaging as it is hoped this will enable characterisation of abnormal areas within the heart in this condition in a way which hasn't been done before.

All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. If successful, this imaging method will enable us to detect differences between different forms of cardiac amyloidosis in a non-invasive way, improving the diagnostic capabilities in this condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Aged over 40 years

• Completion of informed consent

• Established diagnosis of cardiac amyloidosis

Exclusion Criteria:

• Inability or unwilling to give informed consent

• Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.

• Major intercurrent illness with life-expectancy <2 years.

• Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)

• Adverse reaction or hypersensitivity to 18F-FDG PET tracer

• NYHA Class IV heart failure

• Patients with atrial fibrillation and poor rate control

• Contraindications to MRI scanning

• Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Other:
• 18F-NaF PET
Hybrid 18F-NaF PET/MR imaging for observational diagnostic purposes

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Research Institute	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial 18F-NaF uptake	Quantification of myocardial PET tracer uptake	1 year