Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Marcelo F. Di Carli, MD, FACC17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sarcoidosis

Interventions

Indium-111 PentreotideDRUG

Gallium-68 DOTATATEDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants Characterized by Abnormal or Negative Uptake

To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.

Time frame: 1 hour

Secondary Outcomes

Effect of Treatment

To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.

Time frame: 1 hour

Data from ClinicalTrials.gov

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