Tc-99m Tilmanocept SPECT/CT imaging for detecting cardiac sarcoidosis

Repurposing Tc 99m Tilmanocept Imaging for Cardiac Sarcoidosis

This trial tries to see if a Tc-99m Tilmanocept SPECT/CT scan can detect cardiac sarcoidosis in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT07159074 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional effort to repurpose Tc-99m Tilmanocept as a SPECT/CT imaging agent for cardiac sarcoidosis. The protocol enrolls two cohorts, including adults with histologically confirmed sarcoidosis who meet guideline-based criteria for cardiac involvement and have recent cardiac PET-CT and cardiac MRI findings. Participants receive an injection of Tc-99m Tilmanocept followed by SPECT/CT imaging, and results will be compared with prior PET and MRI findings to characterize tracer uptake. The study is conducted at Duke University Hospital in collaboration with the Foundation for Sarcoidosis Research to determine whether this agent can reliably identify cardiac inflammation or scar.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed sarcoidosis who meet 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis and who have recent cardiac PET-CT and cardiac MRI with compatible delayed enhancement are ideal candidates.

Not a fit: Patients without evidence of cardiac involvement, those unable to undergo nuclear imaging, pregnant women, or children under 18 are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this imaging approach could provide a more widely available SPECT/CT option to identify cardiac sarcoidosis and help guide treatment decisions.

How similar studies have performed: FDG PET and MRI have established roles in detecting cardiac sarcoidosis, but repurposing Tc-99m Tilmanocept for cardiac imaging is a novel approach with limited prior data.

Eligibility criteria

Inclusion Criteria:

Cohort 1:

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.
2. Women of reproductive potential must have a negative urine pregnancy test at the time of the study.
3. The participant is at least 18 years of age.
4. The participant has a histological diagnosis sarcoidosis and meets 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis.
5. The participant has had a clinically indicated cardiac PET-CT showing cardiac activity in the past 14 days.
6. 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:

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.
2. Women of reproductive potential must have a negative urine pregnancy test at the time of the study.
3. The participant is at least 18 years of age.
4. Cardiac sarcoidosis has been clinically excluded.
5. 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:

1. The participant is pregnant or lactating.
2. The participant size or weight is not compatible with imaging per the investigator.
3. The participant has renal insufficiency as demonstrated by a glomerular filtration rate of \< 30 mL/min.
4. 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.
5. 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.
6. The participant has a known allergy to or has had an adverse reaction to dextran exposure.
7. The participant has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration (Day 0).
8. The participant has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept (Day 0).

Where this trial is running

Durham, North Carolina

• Duke University Hospital — Durham, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Ravi Karra, MD — Duke Health
• Study coordinator: Shaheela Fnu

Conditions Cardiac Sarcoidosis