Actively Recruiting
Repurposing Tc 99m Tilmanocept Imaging for Cardiac Sarcoidosis
Led by Duke University · Updated on 2026-03-27
15
Participants Needed
1
Research Sites
4 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
Researchers are evaluating whether Tc 99m Tilmanocept SPECT/CT imaging can identify cardiac sarcoidosis, a condition that affects the heart. This Phase 2 study includes participants with confirmed cardiac sarcoidosis showing active inflammation on recent cardiac PET-CT scans or those with cardiomyopathy where sarcoidosis has been ruled out. The goal is to understand how tilmanocept imaging compares to other established imaging methods for cardiac sarcoidosis. Participants will receive Tc 99m tilmanocept either through an intravenous (IV) injection or a subcutaneous (SC) injection, followed by SPECT-CT imaging to capture detailed heart images. The study has two groups: one with active cardiac sarcoidosis and one with non-sarcoidosis cardiomyopathy. Imaging will be done after administration of the study drug by either IV or SC route, and comparisons will be made with PET-CT and cardiac MRI results. During the study, participants will undergo imaging scans to assess tilmanocept uptake in the heart compared to other imaging methods. Researchers will measure correlations between tilmanocept imaging and PET-CT or MRI findings using a standard 17-segment heart model. Safety will be monitored through laboratory tests and clinical evaluations for up to one year. Participants will be involved in study visits around the time of their scans and monitored for any adverse events.
CONDITIONS
Brief Title
Repurposing Tilmanocept for Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide written informed consent with HIPAA or equivalent authorization before any study procedures.
- Women who can become pregnant must have a negative urine pregnancy test at the time of the study.
- Participants must be at least 18 years old.
- For cohort 1: Participants must have a histological diagnosis of sarcoidosis meeting 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis.
- For cohort 1: Participants must have had a clinically indicated cardiac PET-CT showing cardiac activity in the past 14 days.
- For cohort 1: Participants must have had a prior cardiac MRI with delayed enhancement consistent with cardiac sarcoidosis.
- For cohort 2: Cardiac sarcoidosis must be clinically excluded.
- For cohort 2: Participants must have an arrhythmogenic, non-ischemic cardiomyopathy with specific arrhythmias or conduction block not due to ischemic heart disease.
You will not qualify if you...
- Participants who are pregnant or lactating.
- Participants whose size or weight is not compatible with imaging.
- Participants with renal insufficiency shown by a glomerular filtration rate below 30 mL/min.
- Participants with hepatic insufficiency shown by ALT or AST levels more than three times the upper normal limit.
- Participants with severe acute or chronic medical or psychiatric conditions or lab abnormalities posing excess risk for study participation.
- Participants with known allergy or adverse reaction to dextran.
- Participants who received an investigational product within 30 days before Tc 99m tilmanocept administration.
- Participants who 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline (one day)
Participants receive an injection of Tc 99m tilmanocept either intravenously or subcutaneously followed by Single Photon Emission Computed Tomography (SPECT-CT) imaging to evaluate cardiac sarcoidosis.
1 imaging visit (in-person)
Duration - 1 year
Participants are monitored for adverse events and clinical laboratory results including hematology, serum chemistry, and vital signs over one year following the imaging procedure.
Periodic visits for clinical laboratory assessments
Trial Site Locations
Total: 1 location
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
S
Shaheela Fnu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here