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

NCT03923049 | Terminated

• 1 other identifier: IRB-300002877
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• diagnosing cardiac sarcoidosis using combined 18F-FDG-PET/MRI examination

  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.

  baseline through 24 hours

Study Arms (1)

PET/MRI

OTHER

Diagnostic testing with simultaneous PET/MRI for cardiac sarcoidosis diagnosis

Diagnostic Test: hybrid PET/MRI

Interventions

hybrid PET/MRI DIAGNOSTIC_TEST

On the day of the procedure, subjects will undergo a PET scan followed by MRI scan.

PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Coronary artery disease
• Insulin dependent diabetes
• Claustrophobia
• Pregnancy/nursing
• Presence of pacemaker or automatic implantable cardioverter-defibrillator
• Impaired renal function (estimated glomerular filtration rate \<45 ml/min/1.73 m2) will be excluded.
• Inability to undergo PET/MRI due to any other condition.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 22, 2019
• Study Start: May 21, 2019
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: April 12, 2024

Record last verified: 2023-12

Locations

US (1)