PET/MR Imaging In Patients With Cardiac Sarcoidosis

NCT03705884 | Completed

• 1 other identifier: AC17010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Sarcoidosis

Outcome Measures

Primary Outcomes (2)

• Myocardial 18F-FDG uptake

  Quantification of myocardial PET tracer uptake before steroid therapy

  Within 1 year

• Myocardial 18F-FDG uptake

  Quantification of myocardial PET tracer uptake after steroid therapy

  Within 1 year

Study Arms (2)

Cardiac Sarcoidosis

OTHER

Patients with an established diagnosis of cardiac sarcoidosis.

Other: 18F-FDG; Drug: Prednisolone

Healthy volunteers

OTHER

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

Other: 18F-FDG; Drug: Prednisolone

Interventions

18F-FDG OTHER

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

Cardiac Sarcoidosis; Healthy volunteers

Prednisolone DRUG

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

Cardiac Sarcoidosis; Healthy volunteers

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Queen's Medical Research Institute

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18; Prednisolone

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Marc R Dweck, MD PhD

  University of Edinburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients and healthy subjects will be allocated in a non-randomised fashion to either corticosteroid or control arms, for parallel comparison within the two groups. The corticosteroid is recognised treatment for the condition and is being used to observe the impact on diagnostic imaging; no treatment effects are being studied or are endpoints of the study (i.e. the study is not a clinical trial of treatment in cardiac sarcoidosis with corticosteroid).

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: October 15, 2018
• Study Start: October 30, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)