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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02812849
Other study ID # 0001
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2016
Est. completion date February 27, 2020

Study information

Verified date October 2020
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 27, 2020
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Cu-64 DOTATATE


Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity to detect cardiac sarcoidosis 1 day at PET/CT examination
Primary Specificity to detect cardiac sarcoidosis 1 day at PET/CT examination
See also
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