PET/MR Imaging In Patients With Cardiac Sarcoidosis
Primary Purpose
Cardiac Sarcoidosis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
18F-FDG
Prednisolone
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Sarcoidosis
Eligibility Criteria
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)
Sites / Locations
- Queen's Medical Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cardiac Sarcoidosis
Healthy volunteers
Arm Description
Patients with an established diagnosis of cardiac sarcoidosis.
Healthy volunteer subjects of similar age and gender to patient cohort.
Outcomes
Primary Outcome Measures
Myocardial 18F-FDG uptake
Quantification of myocardial PET tracer uptake before steroid therapy
Myocardial 18F-FDG uptake
Quantification of myocardial PET tracer uptake after steroid therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT03705884
First Posted
August 8, 2018
Last Updated
October 12, 2018
Sponsor
University of Edinburgh
1. Study Identification
Unique Protocol Identification Number
NCT03705884
Brief Title
PET/MR Imaging In Patients With Cardiac Sarcoidosis
Official Title
Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Sarcoidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Sarcoidosis
Arm Type
Other
Arm Description
Patients with an established diagnosis of cardiac sarcoidosis.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteer subjects of similar age and gender to patient cohort.
Intervention Type
Other
Intervention Name(s)
18F-FDG
Intervention Description
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
Primary Outcome Measure Information:
Title
Myocardial 18F-FDG uptake
Description
Quantification of myocardial PET tracer uptake before steroid therapy
Time Frame
Within 1 year
Title
Myocardial 18F-FDG uptake
Description
Quantification of myocardial PET tracer uptake after steroid therapy
Time Frame
Within 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas B Spath
Phone
0131 242 6515
Email
nick.spath@ed.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sponsor Representative
Phone
0131 242 3330
Email
enquiries@accord.scot
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc R Dweck, MD PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Study Director
Facility Information:
Facility Name
Queen's Medical Research Institute
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas B Spath, MBBS BSc
Phone
0131 242 6515
Email
nick.spath@ed.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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PET/MR Imaging In Patients With Cardiac Sarcoidosis
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