Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

May 10, 2016 updated by: Lars Christian Gormsen

Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis

Description

Inclusion Criteria:

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

Exclusion Criteria:

  • Ischemic heart disease
  • Diabetes
  • Cardiomyopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sarcoidosis patients
Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
01/01/2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Christian Gormsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (ESTIMATE)

November 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SarcoidosisPET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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