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PET/MR Imaging In Patients With Cardiac Sarcoidosis

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ClinicalTrials.gov Identifier: NCT03705884
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cardiac Sarcoidosis Other: 18F-FDG Drug: Prednisolone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cardiac Sarcoidosis
Patients with an established diagnosis of cardiac sarcoidosis.
Other: 18F-FDG
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.

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

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




Primary Outcome Measures :
  1. Myocardial 18F-FDG uptake [ Time Frame: Within 1 year ]
    Quantification of myocardial PET tracer uptake before steroid therapy

  2. Myocardial 18F-FDG uptake [ Time Frame: Within 1 year ]
    Quantification of myocardial PET tracer uptake after steroid therapy



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705884


Contacts
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Contact: Nicholas B Spath 0131 242 6515 nick.spath@ed.ac.uk
Contact: Sponsor Representative 0131 242 3330 enquiries@accord.scot

Locations
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United Kingdom
Queen's Medical Research Institute Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4TJ
Contact: Nicholas B Spath, MBBS BSc    0131 242 6515    nick.spath@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
Investigators
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Study Director: Marc R Dweck, MD PhD University of Edinburgh

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03705884     History of Changes
Other Study ID Numbers: AC17010
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Fluorodeoxyglucose F18
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action