Trial record 2 of 39 for:    Open Studies | "Sarcoidosis"

Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
Lars Christian Gormsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01729169
First received: November 13, 2012
Last updated: November 26, 2012
Last verified: November 2012
  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 University of Aarhus:

Primary Outcome Measures:
  • Cardiac sarcoidosis - Sensitivity [ Time Frame: 01/01/2015 ] [ Designated as safety issue: No ]
    Ability to correctly identify patients with cardiac sarcoidosis


Secondary Outcome Measures:
  • Myocardial cardiac glucose uptake assessed by Cardiac SUV [ Time Frame: 01/01/2015 ] [ Designated as safety issue: No ]
    Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.


Estimated Enrollment: 16
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729169

Contacts
Contact: Lars C Gormsen, MD PhD +4578456205 lars.christian.gormsen@ki.au.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Lars C Gormsen, MD PhD         
Sponsors and Collaborators
Lars Christian Gormsen
  More Information

No publications provided

Responsible Party: Lars Christian Gormsen, Consultant, MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01729169     History of Changes
Other Study ID Numbers: SarcoidosisPET
Study First Received: November 13, 2012
Last Updated: November 26, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: The National Committee on Health Research Ethics

Keywords provided by University of Aarhus:
Sarcoidosis
Cardiac sarcoidosis
18-FDG PET
68Ga-DOTANOC PET

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 18, 2014