Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

NCT ID: NCT01729169

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-01-31

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.

Conditions

Sarcoidosis; Cardiac Sarcoidosis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Sarcoidosis patients

Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Biopsy proven sarcoidosis
• Suspected cardiac sarcoidosis

Exclusion Criteria

• Ischemic heart disease
• Diabetes
• Cardiomyopathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lars Christian Gormsen

OTHER

Sponsor Role: lead

Responsible Party

Lars Christian Gormsen

Consultant, MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

References

Gormsen LC, Haraldsen A, Kramer S, Dias AH, Kim WY, Borghammer P. A dual tracer (68)Ga-DOTANOC PET/CT and (18)F-FDG PET/CT pilot study for detection of cardiac sarcoidosis. EJNMMI Res. 2016 Dec;6(1):52. doi: 10.1186/s13550-016-0207-6. Epub 2016 Jun 17.

Reference Type: DERIVED

PMID: 27316444 (View on PubMed)

Other Identifiers

SarcoidosisPET

Identifier Type: -

Identifier Source: org_study_id