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Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01729169
First Posted: November 20, 2012
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lars Christian Gormsen, Aarhus University Hospital
  Purpose
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.

Condition
Sarcoidosis Cardiac Sarcoidosis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization

Resource links provided by NLM:


Further study details as provided by Lars Christian Gormsen, Aarhus University Hospital:

Primary Outcome Measures:
  • Cardiac sarcoidosis - Sensitivity [ Time Frame: 01/01/2015 ]
    Ability to correctly identify patients with cardiac sarcoidosis


Secondary Outcome Measures:
  • Myocardial cardiac glucose uptake assessed by Cardiac SUV [ Time Frame: 01/01/2015 ]
    Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.


Enrollment: 19
Study Start Date: June 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sarcoidosis patients
Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis
Criteria

Inclusion Criteria:

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

Exclusion Criteria:

  • Ischemic heart disease
  • Diabetes
  • Cardiomyopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729169


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Lars Christian Gormsen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Christian Gormsen, Consultant, MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01729169     History of Changes
Other Study ID Numbers: SarcoidosisPET
First Submitted: November 13, 2012
First Posted: November 20, 2012
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by Lars Christian Gormsen, Aarhus University Hospital:
Sarcoidosis
Cardiac sarcoidosis
18-FDG PET
68Ga-DOTANOC PET

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases