Actively Recruiting
Repurposing Tilmanocept for Cardiac Sarcoidosis
Led by Duke University · Updated on 2026-03-27
15
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
F
Foundation for Sarcoidosis Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.
CONDITIONS
Official Title
Repurposing Tilmanocept for Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided written informed consent with HIPAA or similar authorization before any study procedures
- Women able to have children must have a negative urine pregnancy test at study time
- Participant is at least 18 years old
- Participant has histological diagnosis of sarcoidosis and meets 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis (Cohort 1)
- Participant had clinically indicated cardiac PET-CT showing cardiac activity within past 14 days (Cohort 1)
- Participant had prior cardiac MRI with delayed enhancement consistent with cardiac sarcoidosis as defined by AHA 2024 statement (Cohort 1)
- Cardiac sarcoidosis has been clinically excluded (Cohort 2)
- Participant has arrhythmogenic, non-ischemic cardiomyopathy with recurrent ventricular tachycardia, atrial arrhythmias, or high-grade AV block not due to ischemic heart disease (Cohort 2)
You will not qualify if you...
- Participant is pregnant or lactating
- Participant size or weight is incompatible with imaging as judged by investigator
- Participant has renal insufficiency with glomerular filtration rate below 30 mL/min
- Participant has liver insufficiency with ALT or AST greater than 3 times upper limit of normal
- Participant has severe acute or chronic medical or psychiatric conditions or lab abnormalities posing excess risk for study participation
- Participant has known allergy or adverse reaction to dextran exposure
- Participant received an investigational product within 30 days before Tc 99m tilmanocept administration
- Participant received any radiopharmaceutical within 7 days or 10 half-lives before Tc 99m tilmanocept administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
S
Shaheela Fnu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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