Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-10-30
2018-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cardiac Sarcoidosis
Patients with an established diagnosis of cardiac sarcoidosis.
18F-FDG
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
Prednisolone
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
Healthy volunteers
Healthy volunteer subjects of similar age and gender to patient cohort.
18F-FDG
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
Prednisolone
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
Interventions
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18F-FDG
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
Prednisolone
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
40 Years
ALL
Yes
Sponsors
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University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Marc R Dweck, MD PhD
Role: STUDY_DIRECTOR
University of Edinburgh
Locations
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Queen's Medical Research Institute
Edinburgh, Midlothian, United Kingdom
Countries
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Other Identifiers
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AC17010
Identifier Type: -
Identifier Source: org_study_id
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