Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

Sarcoidosis Clinical Trial

Official title:

Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729169
• Other study ID #: SarcoidosisPET
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: May 10, 2016
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: The National Committee on Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy proven sarcoidosis

• Suspected cardiac sarcoidosis

Exclusion Criteria:

• Ischemic heart disease

• Diabetes

• Cardiomyopathy

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Sarcoidosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Lars Christian Gormsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac sarcoidosis - Sensitivity	Ability to correctly identify patients with cardiac sarcoidosis	01/01/2015	No
Secondary	Myocardial cardiac glucose uptake assessed by Cardiac SUV	Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.	01/01/2015	No