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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

Clinicaltrials.gov identifier NCT03923049

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted October 17, 2019

Study Description

Brief summary:

The purpose and objectives of the study is to establish the feasibility of the simultaneous PET/MR in patients with cardiac sarcoidosis, determine relationships between various imaging biomarkers like extracellular volume (ECV) and standardized uptake values (SUV) from FDG-PET and to evaluate the diagnostic accuracy of the simultaneous method in comparison to the PET/CT and cardiac MRI.

  • Condition or Disease:Cardiac Sarcoidosis
  • Intervention/Treatment: Diagnostic Test: hybrid PET/MRI
  • Phase: N/A
Detailed Description

Patients who meet the inclusion criteria and agree to the study will be recruited from the Kirklin Clinic and UAB hospitals who will be undergoing FDG-PET/CT for cardiac study as part of their standard of care to diagnose cardiac sarcoidosis. MRI and FDG-PET screening questionnaire will be completed. A chart review will be completed to obtain data from patient medical records pertaining to study including age, gender, race, weight, height, vital signs, social and family history, past medical history especially if there is any history of hypertension, diabetes, high cholesterol levels, heart failure or history of lung diseases, lab results including brain natriuretic peptide levels, creatinine, hemoglobin, coagulation parameters, results of stress test/left heart catheterization, prior echocardiography if available. The CMR will be done solely for research purposes. The patient will be in the PET/MRI scanner for cardiac study only for 60-90 minutes, Finally, multi-sequence, multi-planar cardiac MR images will be acquired to assess cardiac chamber size, regional wall motion abnormalities, ejection fraction, left ventricular perfusion(using gadolinium-based agent) and late gadolinium enhancement. The investigators will also conduct MRI examinations on 5 healthy volunteers to establish cardiac MRI protocol for the PET/MRI scanner. These scans will not involve any FDG administration to the healthy volunteers. These will involve cardiac MRI examinations to determine the feasibility and quality of MRI scans with the new scanner.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Other: PET/MRI
Diagnostic testing with simultaneous PET/MRI for cardiac sarcoidosis diagnosis
Diagnostic Test: hybrid PET/MRI
On the day of the procedure, subjects will undergo a PET scan followed by MRI scan.
Outcome Measures
  • Primary Outcome Measures: 1. diagnosing cardiac sarcoidosis using combined 18F-FDG-PET/MRI examination [ Time Frame: baseline through 24 hours ]
    diagnostic accuracy of FDG-PET/MRI test will be determined by comparing the PET/MRI test against the Heart Rhythm Society (HRS) criteria which is the standard of reference.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1.Subjects older than 18 years of age with high suspicion of cardiac sarcoidosis and/or
biopsy proven extracardiac sarcoidosis and/or positive HRS criteria will be enrolled.

Exclusion Criteria:

1. Coronary artery disease

2. Insulin dependent diabetes

3. Claustrophobia

4. Pregnancy/nursing

5. Presence of pacemaker or automatic implantable cardioverter-defibrillator

6. Impaired renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2) will be excluded. 7. Inability to undergo PET/MRI due to any other condition.

Contacts and Locations
Contacts

Contact: Sudeep Aryal, MD 205-975-9859 saryal@uabmc.edu

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham

Sponsors and Collaborators

University of Alabama at Birmingham

More Information
  • Responsible Party: University of Alabama at Birmingham
  • ClinicalTrials.gov Identifier: NCT03923049 History of Changes
  • Other Study ID Numbers: IRB-300002877
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: October 17, 2019
  • Last Verified: October 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Sarcoidosis