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Somatostatin Receptor Imaging in Cardiac Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02812849
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Rasmus S. Ripa, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Sarcoidosis Drug: Cu-64 DOTATATE

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Somatostatin Receptor Imaging in Cardiac Sarcoidosis
Study Start Date : June 2016
Estimated Primary Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

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



Primary Outcome Measures :
  1. Sensitivity to detect cardiac sarcoidosis [ Time Frame: 1 day at PET/CT examination ]
  2. Specificity to detect cardiac sarcoidosis [ Time Frame: 1 day at PET/CT examination ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy
Criteria

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


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): NCT02812849


Contacts
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Contact: Rasmus S Ripa, MD, DMSc +4535453545
Contact: Finn Gustafsson, MD, DMSc

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Finn Gustafsson, MD, DMSc         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Rasmus S Ripa, MD, DMSc Rigshospitalet, Denmark

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Responsible Party: Rasmus S. Ripa, MD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02812849     History of Changes
Other Study ID Numbers: 0001
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs