Repurposing Tilmanocept for Cardiac Sarcoidosis

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07159074
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cardiac Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tc 99m tilmanocept — DRUG
    150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through an IV route of injection. SPECT-CT imaging will then be performed.
  • Tc 99m tilmanocept — DRUG
    150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through a SC route of injection. SPECT-CT imaging will then be performed.

Study Details

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

Key Dates

Start date
Sep 17, 2025
Status verified
Oct 2025
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Tc 99m Tilmanocept SPECT CT imaging (intravenously)
    Participants with known cardiac sarcoidosis and a cardiac positron emission tomography (PET) imaging study showing active inflammation in the past 14 days or participants with a cardiomyopathy for which sarcoidosis has been excluded will undergo Single Photon Emission Computed Tomography (SPECT-CT) imaging after administration of Tc 99m Tilmanocept intravenously (IV).
  • Experimental: Tc 99m Tilmanocept SPECT CT imaging (subcutaneously)
    Participants with known cardiac sarcoidosis and a cardiac positron emission tomography (PET) imaging study showing active inflammation in the past 14 days or participants with a cardiomyopathy for which sarcoidosis has been excluded will undergo Single Photon Emission Computed Tomography (SPECT-CT) imaging after administration of Tc 99m Tilmanocept subcutaneously (SC).

Primary Outcome Measure

Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with fluorodeoxyglucose (FDG) uptake on cardiac PET-CT. For each imaging modality, a standard 17-segment cardiac model will be used. [ Time Frame: At the time of the scan (Baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
Ravi Karra, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University Hospital· Durham, NC

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