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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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).
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|