Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
March 25, 2020
CompletedApril 9, 2020
April 1, 2020
2.8 years
September 9, 2015
January 27, 2020
April 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effect of Treatment
1 hour
Study Arms (2)
Indium-111 Pentreotide (OctreoScan)
EXPERIMENTALPatients 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.
Gallium-68 DOTATATE
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcelo F. Di Carli, MD, FACClead
- Mallinckrodtcollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations include small sample size (we only included individuals with myocardial FDG uptake) and there is no gold standard for the diagnosis of inflammation.
Results Point of Contact
- Title
- Paco Bravo, MD
- Organization
- University of Pennslyvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief of Nuclear Medicine
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 10, 2015
Study Start
October 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
April 9, 2020
Results First Posted
March 25, 2020
Record last verified: 2020-04