Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET
Recruitment status was Recruiting
Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has proved effective and cardiac biopsies have a very low sensitivity. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of fasting has previously been demonstrated to have reasonable accuracy, however, in some patients physiological FDG uptake in the cardiac region hampers correct identification of sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue Nal3-octreotide (NOC) and gallium Ga 68-labeled 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization|
- Cardiac sarcoidosis - Sensitivity [ Time Frame: 01/01/2015 ] [ Designated as safety issue: No ]Ability to correctly identify patients with cardiac sarcoidosis
- Myocardial cardiac glucose uptake assessed by Cardiac SUV [ Time Frame: 01/01/2015 ] [ Designated as safety issue: No ]Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis
- Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin blockade (300 microgram/hour)/Heparin infusion.
- Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET preceded by at least 6 hours fasting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729169
|Contact: Lars C Gormsen, MD PhDfirstname.lastname@example.org|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Principal Investigator: Lars C Gormsen, MD PhD|