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OpenTrials
Completed

NCT Number: NCT03626584

PET/MR Imaging In Patients With Cardiac Amyloidosis

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

18F-NaF PET

Other

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

Primary outcomes

  1. Myocardial 18F-NaF uptake

    Time frame: 1 year

    Quantification of myocardial PET tracer uptake

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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