Somatostatin Receptor Imaging in Cardiac Sarcoidosis

Withdrawn

• Conditions: Cardiac Sarcoidosis
• Interventions: Drug: Cu-64 DOTATATE

• Registration Number: NCT02812849
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2019-11
• Study Completion: 2020-02-27
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected cardiac sarcoidosis	Cu-64 DOTATATE	Cu-64 DOTATATE PET/CT or PET/MRI
Known cardiac sarcoidosis	Cu-64 DOTATATE	Cu-64 DOTATATE PET/CT or PET/MRI
Other inflammatory cardiac disease	Cu-64 DOTATATE	Cu-64 DOTATATE PET/CT or PET/MRI

Primary Outcome Measures

Name	Time	Method
Sensitivity to detect cardiac sarcoidosis	1 day at PET/CT examination
Specificity to detect cardiac sarcoidosis	1 day at PET/CT examination

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark