Skip to main content
OpenTrials
Completed

NCT Number: NCT02546388

Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indium-111 Pentreotide

Drug

Other names: OctreoScan

Gallium-68 DOTATATE

Drug

Primary outcomes

  1. Number of Participants Characterized by Abnormal or Negative Uptake

    Time frame: 1 hour

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

Secondary outcomes

  1. Effect of Treatment

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

Marcelo F. Di Carli, MD, FACC

Other

Collaborators

  • Mallinckrodt

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2015
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.