Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03923049
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Navkaranbir Bajaj, University of Alabama at Birmingham

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 Intervention/treatment Phase
Cardiac Sarcoidosis Diagnostic Test: hybrid PET/MRI Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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): NCT03923049


Contacts
Layout table for location contacts
Contact: Sudeep Aryal, MD 205-975-9859 saryal@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham

Layout table for additonal information
Responsible Party: Navkaranbir Bajaj, Principal Investigator, 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: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action