N/A N=17 Diagnostic

Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Sarcoidosis

Bottom Line

View on ClinicalTrials.gov: NCT02546388 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Number of Participants Characterized by Abnormal or Negative Uptake — 4; 3; 6 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Indium-111 Pentreotide (Drug); Gallium-68 DOTATATE (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Marcelo F. Di Carli, MD, FACC
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Characterized by Abnormal or Negative Uptake	4; 3; 6	—
SECONDARY Effect of Treatment	1; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02546388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.