Repurposing Tilmanocept for Cardiac Sarcoidosis

Официальное название

Repurposing Tc 99m Tilmanocept Imaging for Cardiac Sarcoidosis

Обзор

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

Вмешательства

• Препарат Tc 99m tilmanocept
  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.
• Препарат Tc 99m tilmanocept
  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.

Первичные конечные точки

• 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. [Срок оценки: At the time of the scan (Baseline)]

Вторичные конечные точки (7)

• Correlation between TUVmax from tilmanocept imaging and SUVmax from FDG-PET imaging. [Срок оценки: 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. [Срок оценки: At the time of the scan (Baseline)]
• Correlation of extracardiac sites with tilmanocept uptake and FDG uptake attributed to sarcoidosis. [Срок оценки: At the time of the scan (Baseline)]
• Difference in percentage of segments with tilmanocept uptake in cohort 1 compared to cohort 2 [Срок оценки: At the time of the scan (Baseline)]
• Adverse events, identified through clinical laboratory results (hematology, serum chemistry, vital signs). [Срок оценки: 1 year]
• Difference in biodistribution measured by cardiac uptake relative to liver uptake [Срок оценки: Baseline]
• Difference in biodistribution measured by uptake of the upper extremity musculature [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Duke University Hospital — Durham

Идентификаторы

NCT: NCT07159074 · PRO00117849

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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