PET Imaging in Patients With Suspected Cardiac Sarcoidosis

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    20
  • sponsor
    University of Pennsylvania
Updated on 15 February 2021

Summary

Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. The study will see how the tracer is taken up in your heart before and after treatment using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Investigators are doing this research study to find out if DOTATATE can help doctors diagnose people with cardiac (heart) sarcoidosis better as well as serve as a follow-up monitoring tool for a response to therapy.

Details
Condition Cardiac Sarcoidosis
Treatment Gallium-68 DOTATATE
Clinical Study IdentifierNCT03746847
SponsorUniversity of Pennsylvania
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants will be 18 years of age
History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation
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 fusion
Any cardiac arrhythmia
Chest pain, dyspnea or syncope without clear etiology
FDG PET/CT scan demonstrating abnormal myocardial FDG uptake
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion Criteria

Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening
History of neuroendocrine tumors
Currently taking the medication Octreotide
Currently on total parenteral nutrition (TPN)
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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