N/A
Completed N=17
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Source: ClinicalTrials.gov NCT02546388 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants Characterized by Abnormal or Negative Uptake — 4; 3; 6 Participants
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.
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 | — |
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
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. Informational only — not medical advice.