NCT03549598

d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.

Conditions

• Cardiac Sarcoidosis

Interventions

Type	Name	Description
DRUG	68Ga-DOTATATE PET/CT	5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
DRUG	18FDG PET/CT scan	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.
DRUG	13NH3 PET/CT scan	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.

Timeline

• Start date: 2018-07-20
• Primary completion: 2019-10-02
• Completion: 2019-10-02
• First posted: 2018-06-08
• Last updated: 2020-10-20
• Results posted: 2020-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study