Repurposing Tilmanocept for Cardiac Sarcoidosis

NCT07159074 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PRO00117849
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• 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.

  At the time of the scan (Baseline)

Secondary Outcomes (7)

• Correlation between TUVmax from tilmanocept imaging and SUVmax from FDG-PET imaging.

  At the time of the scan (Baseline)

• Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with hyperenhancement on cardiac MRI. For each imaging modality, a standard 17-segment cardiac model will be used.

  At the time of the scan (Baseline)

• Correlation of extracardiac sites with tilmanocept uptake and FDG uptake attributed to sarcoidosis.

  At the time of the scan (Baseline)

• Difference in percentage of segments with tilmanocept uptake in cohort 1 compared to cohort 2

  At the time of the scan (Baseline)

• Adverse events, identified through clinical laboratory results (hematology, serum chemistry, vital signs).

  1 year

Study Arms (2)

Tc 99m Tilmanocept SPECT CT imaging (intravenously)

EXPERIMENTAL

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).

Drug: Tc 99m tilmanocept

Tc 99m Tilmanocept SPECT CT imaging (subcutaneously)

EXPERIMENTAL

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).

Drug: Tc 99m tilmanocept

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 SPECT CT imaging (intravenously)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead
• Foundation for Sarcoidosis Research: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Study Officials

• Ravi Karra, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaheela Fnu

CONTACT

919-681-2723; ravi.karra@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 8, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)