Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET
Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization
1 other identifier
observational
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMay 11, 2016
May 1, 2016
2.6 years
November 13, 2012
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac sarcoidosis - Sensitivity
Ability to correctly identify patients with cardiac sarcoidosis
01/01/2015
Secondary Outcomes (1)
Myocardial cardiac glucose uptake assessed by Cardiac SUV
01/01/2015
Study Arms (1)
Sarcoidosis patients
Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis
Eligibility Criteria
Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis
You may qualify if:
- Biopsy proven sarcoidosis
- Suspected cardiac sarcoidosis
You may not qualify if:
- Ischemic heart disease
- Diabetes
- Cardiomyopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, 8000, Denmark
Related Publications (1)
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.
PMID: 27316444DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant, MD PhD
Study Record Dates
First Submitted
November 13, 2012
First Posted
November 20, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
May 11, 2016
Record last verified: 2016-05