NCT07159074招募中2 期
Repurposing Tc 99m Tilmanocept Imaging for Cardiac Sarcoidosis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •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
排除标准
- •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).
研究组 & 干预措施
Tc 99m Tilmanocept SPECT CT imaging
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.
干预措施: Tc 99m tilmanocept (Drug)
结局指标
主要结局
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.
时间窗: At the time of the scan (Baseline)
次要结局
- 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)
研究者
研究点 (1)
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