d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Cardiac Sarcoidosis

Treatments: Drug: 68Ga-DOTATATE PET/CT; Drug: 13NH3 PET/CT scan; Drug: 18FDG PET/CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03549598

18-000393

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion criteria

• Pregnant
• Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

68Ga-DOTATATE PET/CT

Experimental group

Description:

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject

Treatment:

Drug: 13NH3 PET/CT scan

Drug: 18FDG PET/CT scan

Drug: 68Ga-DOTATATE PET/CT