PET/MR Imaging In Patients With Cardiac Sarcoidosis

Not Applicable

Completed

• Conditions: Cardiac Sarcoidosis
• Interventions: Other: 18F-FDG; Drug: Prednisolone

• Registration Number: NCT03705884
• Lead Sponsor: University of Edinburgh

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-15
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Sarcoidosis	18F-FDG	Patients with an established diagnosis of cardiac sarcoidosis.
Healthy volunteers	18F-FDG	Healthy volunteer subjects of similar age and gender to patient cohort.
Cardiac Sarcoidosis	Prednisolone	Patients with an established diagnosis of cardiac sarcoidosis.
Healthy volunteers	Prednisolone	Healthy volunteer subjects of similar age and gender to patient cohort.

Primary Outcome Measures

Name	Time	Method
Myocardial 18F-FDG uptake	Within 1 year	Quantification of myocardial PET tracer uptake after steroid therapy

Trial Locations

Locations (1)

Queen's Medical Research Institute; 🇬🇧 Edinburgh, Midlothian, United Kingdom