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

NCT ID: NCT03923049

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2020-12-02

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.

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.

Conditions

Cardiac Sarcoidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET/MRI

Diagnostic testing with simultaneous PET/MRI for cardiac sarcoidosis diagnosis

Group Type: OTHER

hybrid PET/MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

hybrid PET/MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Navkaranbir Bajaj

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB-300002877

Identifier Type: -

Identifier Source: org_study_id