Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis
• Interventions: Drug: Indium-111 Pentreotide; Drug: Gallium-68 DOTATATE

• Registration Number: NCT02546388
• Lead Sponsor: Marcelo F. Di Carli, MD, FACC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Study Start: 2015-10
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2020-01-27
• Results First Submitted QC: 2020-03-10
• Results First Posted: 2020-03-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indium-111 Pentreotide (OctreoScan)	Indium-111 Pentreotide	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.
Gallium-68 DOTATATE	Gallium-68 DOTATATE	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Characterized by Abnormal or Negative Uptake	1 hour	To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.

Secondary Outcome Measures

Name	Time	Method
Effect of Treatment	1 hour	To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States