Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Marcelo F. Di Carli, MD, FACC

Status: Completed

Conditions: Sarcoidosis

Treatments: Drug: Gallium-68 DOTATATE; Drug: Indium-111 Pentreotide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02546388

2015P001421

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Indium-111 Pentreotide (OctreoScan)

Experimental group

Description:

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.

Treatment:

Drug: Indium-111 Pentreotide

Gallium-68 DOTATATE

Experimental group

Description:

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.

Treatment:

Drug: Gallium-68 DOTATATE