d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)
Exclusion Criteria
- •Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
Arms & Interventions
68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Intervention: 68Ga-DOTATATE PET/CT (Drug)
68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Intervention: 18FDG PET/CT scan (Drug)
68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Intervention: 13NH3 PET/CT scan (Drug)
Outcomes
Primary Outcomes
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
Time Frame: 3 days
The number of subjects with areas of abnormal myocardial increased focal uptake
18FDG Uptake With Cardia Sarcoidosis (CS)
Time Frame: 2 days
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
Time Frame: 2 days
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Secondary Outcomes
- Physician Confidence in Study Interpretation(2 days)
- Subject Satisfaction(2 days)
Investigators
John P. Bois, M.D.
Assistant Professor of Medicine
Mayo Clinic