Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
NCT ID: NCT02546388
Last Updated: 2020-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2015-10-31
2018-08-31
Brief Summary
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OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Indium-111 Pentreotide (OctreoScan)
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.
Indium-111 Pentreotide
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.
Gallium-68 DOTATATE
Interventions
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Indium-111 Pentreotide
Gallium-68 DOTATATE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Marcelo F. Di Carli, MD, FACC
OTHER
Responsible Party
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Marcelo F. Di Carli, MD, FACC
Chief of Nuclear Medicine
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015P001421
Identifier Type: -
Identifier Source: org_study_id
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