Somatostatin Receptor Imaging in Cardiac Sarcoidosis

October 12, 2020 updated by: Rasmus S. Ripa, Rigshospitalet, Denmark
The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
      • Copenhagen, Denmark
        • Rigshospitalet

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 suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy

Description

Inclusion Criteria:

Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)

Exclusion Criteria:

Infection Pregnancy Severe claustrophobia Weight >140 kg

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suspected cardiac sarcoidosis
Cu-64 DOTATATE PET/CT or PET/MRI
Drug: Cu-64 DOTATATE
Known cardiac sarcoidosis
Cu-64 DOTATATE PET/CT or PET/MRI
Drug: Cu-64 DOTATATE
Other inflammatory cardiac disease
Cu-64 DOTATATE PET/CT or PET/MRI
Drug: Cu-64 DOTATATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity to detect cardiac sarcoidosis
Time Frame: 1 day at PET/CT examination
1 day at PET/CT examination
Specificity to detect cardiac sarcoidosis
Time Frame: 1 day at PET/CT examination
1 day at PET/CT examination

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Rasmus S Ripa, MD, DMSc, Rigshospitalet, Denmark

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, 2016

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Actual)

February 27, 2020

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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