Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546388
• Other study ID #: 2015P001421
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: August 2018

Study information

• Verified date: April 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• Indium-111 Pentreotide

• Gallium-68 DOTATATE

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Marcelo F. Di Carli, MD, FACC	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of Treatment	To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.	1 hour