d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Conditions
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Cardiac Sarcoidosis

Intervention / Treatment
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* Drug: 68Ga-DOTATATE PET/CT
* Drug: 18FDG PET/CT scan
* Drug: 13NH3 PET/CT scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTATATE PET/CT<br>68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject | Drug: 68Ga-DOTATATE PET/CT<br>* 5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.<br>Drug: 18FDG PET/CT scan<br>* 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.<br>Drug: 13NH3 PET/CT scan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) | The number of subjects with areas of abnormal myocardial increased focal uptake | 3 days | 
| 18FDG Uptake With Cardia Sarcoidosis (CS) | The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan | 2 days | 
| 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) | The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Confidence in Study Interpretation | A Physician survey will be conducted for those cardiac imagers assessing both the DOTATATE and FDG studies to determine their confidence level in interpreting the studies and if one study was easier to interpret than the other | 2 days | 
| Subject Satisfaction | A patient survey will be conducted after each subject has undergone both the DOTATE and the FDG scans. Patient satisfaction will be measured by the question, Which study did you prefer? Subject to circle one of the following: 18FDG, 68Ga-DOTATATE or Equal | 2 days |