Repurposing Tilmanocept for Cardiac Sarcoidosis | NCT07159074

NCT07159074

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Foundation for Sarcoidosis Research	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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).