PET/MR Imaging In Patients With Cardiac Sarcoidosis

University of Edinburgh

Status: Completed

Conditions: Cardiac Sarcoidosis

Treatments: Drug: Prednisolone; Other: 18F-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT03705884

AC17010

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cardiac Sarcoidosis

Other group

Description:

Patients with an established diagnosis of cardiac sarcoidosis.

Treatment:

Drug: Prednisolone

Other: 18F-FDG

Healthy volunteers

Other group

Description:

Healthy volunteer subjects of similar age and gender to patient cohort.

Treatment:

Drug: Prednisolone

Other: 18F-FDG