Repurposing Tilmanocept for Cardiac Sarcoidosis

Inclusion criteria

Cohort 1:

• 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.
• The participant has had a clinically indicated cardiac PET-CT showing cardiac activity in the past 14 days.
• The participant has had a prior cardiac MRI with delayed enhancement in pattern consistent with cardiac sarcoidosis as defined in the AHA Scientific Statement on the Diagnosis and Management of Cardiac Sarcoidosis (2024).

Cohort 2:

• 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.
• Cardiac sarcoidosis has been clinically excluded.
• The participant has an arrhythmogenic, non-ischemic cardiomyopathy defined as the presence of a cardiomyopathy with a history of recurrent (more than 1 episode) ventricular tachycardia, atrial arrhythmias, high grade AV block not due to ischemic heart disease

Exclusion criteria

• 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.
• The participant has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study participation.
• The participant has a known allergy to or has had an adverse reaction to dextran exposure.
• The participant has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration (Day 0).
• The participant has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept (Day 0).