PET/MR Imaging In Patients With Cardiac Amyloidosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Amyloidosis

Intervention / Treatment
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* Other: 18F-NaF PET


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Amyloidosis Patients<br>Patients with established diagnosis of cardiac amyloidosis. | Other: 18F-NaF PET<br>* Hybrid 18F-NaF PET/MR imaging for observational diagnostic purposes<br>|
| Healthy Volunteers<br>Healthy volunteer subjects of similar age and gender to patient cohort. | Other: 18F-NaF PET<br>* Hybrid 18F-NaF PET/MR imaging for observational diagnostic purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial 18F-NaF uptake | Quantification of myocardial PET tracer uptake | 1 year |