Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Study Overview
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Brief Summary
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The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better. OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.

Official Title
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Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Conditions
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Sarcoidosis

Intervention / Treatment
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* Drug: Indium-111 Pentreotide
* Drug: Gallium-68 DOTATATE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 18 or older Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium. Exclusion Criteria: Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart. Patients with history of neuroendocrine tumors (specially insulinomas) Patients taking the medication Octreotide Patients on total parenteral nutrition (TPN) Women who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indium-111 Pentreotide (OctreoScan)<br>Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection. | Drug: Indium-111 Pentreotide<br> <br> * Other names: OctreoScan;|
| Experimental: Gallium-68 DOTATATE<br>Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging 1 hour after injection for DOTATATE. | Drug: Gallium-68 DOTATATE<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Characterized by Abnormal or Negative Uptake | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Treatment | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. | 1 hour |