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OpenTrials
Completed

NCT Number: NCT03705884

PET/MR Imaging In Patients With Cardiac Sarcoidosis

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 sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.

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. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.

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Key information

Conditions

Cardiac Sarcoidosis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's Medical Research Institute

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Cardiac Sarcoidosis Patients:

  • Aged over 40 years
  • Completion of informed consent
  • Established diagnosis of cardiac sarcoidosis
  • Established diagnosis as per HRS recommended diagnostic criteria

Healthy Volunteers:

  • Aged over 40
  • Completion of informed consent

Exclusion criteria

  • All participants:
  • 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-FDG

Other

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

Prednisolone

Drug

Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)

Primary outcomes

  1. Myocardial 18F-FDG uptake

    Time frame: Within 1 year

    Quantification of myocardial PET tracer uptake before steroid therapy

  2. Myocardial 18F-FDG uptake

    Time frame: Within 1 year

    Quantification of myocardial PET tracer uptake after steroid therapy

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 Sarcoidosis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 15, 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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