Repurposing Tilmanocept for Cardiac Sarcoidosis
ConditionCardiac Sarcoidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Tc 99m tilmanocept
Drug150 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
Drug150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through a SC route of injection. SPECT-CT imaging will then be performed.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Tc 99m Tilmanocept SPECT CT imaging (intravenously)Experimental treatment 1 intervention
Group B: Tc 99m Tilmanocept SPECT CT imaging (subcutaneously)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
At the time of the scan (Baseline)Secondary outcomes
1
Correlation between TUVmax from tilmanocept imaging and SUVmax from FDG-PET imaging.
Time frame
At the time of the scan (Baseline)2
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.
Time frame
At the time of the scan (Baseline)3
Correlation of extracardiac sites with tilmanocept uptake and FDG uptake attributed to sarcoidosis.
Time frame
At the time of the scan (Baseline)4
Difference in percentage of segments with tilmanocept uptake in cohort 1 compared to cohort 2
Time frame
At the time of the scan (Baseline)Sponsors and contacts
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Duke University
Lead sponsor
Foundation for Sarcoidosis Research
Collaborator
Source ClinicalTrials.gov