Repurposing Tilmanocept for Cardiac Sarcoidosis
ConditionCardiac Sarcoidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.
Eligibility criteria
Qualifiers
The participant has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) or equivalent authorization before the initiation of any study-related procedures.
Women of reproductive potential must have a negative urine pregnancy test at the time of the study.
The participant is at least 18 years of age.
The participant has a histological diagnosis sarcoidosis and meets 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis.
Disqualifiers
The participant is pregnant or lactating.
The participant size or weight is not compatible with imaging per the investigator.
The participant has renal insufficiency as demonstrated by a glomerular filtration rate of < 30 mL/min.
The participant has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 3 times the upper limit of normal.
Trial design
Treatments tested in this trial
- Tc 99m tilmanocept
- Tc 99m tilmanocept
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
Foundation for Sarcoidosis Research
Collaborator
Source ClinicalTrials.gov