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Status:

RECRUITING

Repurposing Tilmanocept for Cardiac Sarcoidosis

Lead Sponsor:

Duke University

Collaborating Sponsors:

Foundation for Sarcoidosis Research

Conditions:

Cardiac Sarcoidosis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

September 17 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT07159074

Start Date

September 17 2025

End Date

December 31 2026

Last Update

October 27 2025

Active Locations (1)

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1

Duke University Hospital

Durham, North Carolina, United States, 27710