Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

Completed

• Conditions: Cardiac Sarcoidosis; Sarcoidosis

• Registration Number: NCT01729169
• Lead Sponsor: Lars Christian Gormsen

Brief Summary

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.

Detailed Description

Intervention:

* 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Biopsy proven sarcoidosis
• Suspected cardiac sarcoidosis

Exclusion Criteria

• Ischemic heart disease
• Diabetes
• Cardiomyopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac sarcoidosis - Sensitivity	01/01/2015	Ability to correctly identify patients with cardiac sarcoidosis

Secondary Outcome Measures

Name	Time	Method
Myocardial cardiac glucose uptake assessed by Cardiac SUV	01/01/2015	Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark