Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01729169

Enrollment

Registered

2012-11-20

Start date

2012-06-30

Completion date

2015-01-31

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Sarcoidosis, Sarcoidosis

Keywords

Sarcoidosis, Cardiac sarcoidosis, 18-FDG PET, 68Ga-DOTANOC PET

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Biopsy proven sarcoidosis * Suspected cardiac sarcoidosis

Exclusion criteria

* Ischemic heart disease * Diabetes * Cardiomyopathy

Design outcomes

Primary

Measure	Time frame	Description
Cardiac sarcoidosis - Sensitivity	01/01/2015	Ability to correctly identify patients with cardiac sarcoidosis

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results