对淀粉样蛋白 124I-AT-01 患者重复进行 PET/CT 成像，以测量器官特异性淀粉样蛋白负荷的变化

124I-AT-01（124I-p5+14，碘-124I evuzamitide）是一种碘-124 (124I) 标记的 45 L-氨基酸肽，适用于 PET/CT 成像。 该肽通过与淀粉样蛋白原纤维和普遍存在的硫酸乙酰肝素蛋白聚糖的多价静电相互作用结合多种形式的淀粉样蛋白。

124I-AT-01 之前已在田纳西大学医学中心进行的开放标签 1/2 期临床试验 AMY1001 中进行了评估（IND# 132282；NCT T03678259）。

在这项重复成像研究中，之前参加 AMY1001 研究并观察到 ​​PET/CT 成像结果呈阳性的患者将接受重复成像，以评估肝脏、脾脏、心脏和肾脏中放射性示踪剂摄取的变化。

• 124I-p5+14
• 碘-124-依扎米肽

For AL, ATTR and all patients, we will correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in disease status (progression, response, or stable state) when this can be established from data (serum biomarkers and cardiac imaging parameters) in the patients' medical record or collected during the AMY1001 trial.

Disease status is categorized based on NTproBNP, creatinine, blood urea nitrogen or alkaline phosphatase compared to baseline values taken at the original scan time or noted in the medical record based on a sum of clinical findings. Progression is defined as a ≥30% increase; Response is defined as a ≥30% decrease; and Stable disease is defined as a <30% increase or decrease.

For AL patients, correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in serum free light chains over the period between imaging studies, when available in the medical record.

Baseline assessments reflect the values assessed during the previous study (NCT03678259). Repeat assessments reflect the values assessed during this current study. The 'change in' values are calculated as the repeat value from this current study minus the baseline value from the previous study (NCT03678259).