CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
68Ga-DOTATATE PET/CT +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03549598
NCT03549598Phase 4Completed
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d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Mayo Clinic·interventional·Posted Jun 8, 2018·Updated Oct 20, 2020

In Brief

A Phase 4 clinical trial evaluating 68Ga-DOTATATE PET/CT, 18FDG PET/CT scan, and 1 other intervention for Cardiac Sarcoidosis. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Sarcoidosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 8, 2018
Enrollment StartJul 20, 2018
Primary CompletionOct 2, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.1 years ago

Interventions

68Ga-DOTATATE PET/CTdrug

5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.

18FDG PET/CT scandrug

This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.

13NH3 PET/CT scandrug

This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.