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Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02546388
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital

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.


Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Indium-111 Pentreotide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Study Start Date : October 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with clinical suspicion of cardiac sarcoidosis
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) or Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection or 1 hour after injection for DOTATATE.
Drug: Indium-111 Pentreotide
Other Name: OctreoScan




Primary Outcome Measures :
  1. Visual signal of OctreoScan or DOTATATE in the heart [ Time Frame: 1 year ]
    To investigate if patients with clinically suspected cardiac sarcoidosis exhibit a myocardial OctreoScan or DOTATATE signal high enough (heart-to-blood pool ratio ≥ 2.0) to be visually detected compared to a control group of individuals (expected heart-to-blood pool ratio of ~ 1.0).


Secondary Outcome Measures :
  1. Early versus delayed imaging [ Time Frame: 1 year ]
    To evaluate whether 4-hour (early) compared to 24-hour (delayed) post-OctreoScan injection imaging yields similar lesion detection performance.

  2. Correlate localization and number of increased foci [ Time Frame: 1 year ]
    To correlate localization and number of increased radiotracer foci between FDG-PET and OctreoScan or between FDG-PET and DOTATATE studies.

  3. Effect of Treatment [ Time Frame: 1 year ]
    To correlate localization and number of increased radiotracer foci between FDG-PET and OctreoScan or between FDG-PET and DOTATATE studies.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546388


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Marcelo F. Di Carli, MD, FACC
Mallinckrodt

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Responsible Party: Marcelo F. Di Carli, MD, FACC, Chief of Nuclear Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02546388     History of Changes
Other Study ID Numbers: 2015P001421
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs