First-in-Human Evaluation of [18F]AldoView: A Highly Selective PET Tracer for Aldosterone Synthase Imaging in Primary Aldosteronism

作者：Tingting Long, Geru Liu, Ming Zhou, Zhen Zhang, Yao Xiao, Huizhu Chen, Ning Peng, Yuzhen Jin, Xiaotong Yao, Yu Gan, Cheng Zhi, Min Luo, Chun Li, Yuan Xiao, Zehao Liu, Min Guo, Zhuying Xia, Min Wang, Jing Wang, Longfei Liu, Xiang‐Hang Luo, Tiejian Jiang, Shuo Hu · 发表于：Clinical Nuclear Medicine · 年份：2025 · DOI：10.1097/rlu.0000000000006014 · 被引用次数：11 · 研究领域：Hormonal Regulation and Hypertension、Renin-Angiotensin System Studies、Adrenal and Paraganglionic Tumors

OBJECTIVES: Aldosterone synthase (CYP11B2) is overexpressed in primary aldosteronism (PA), making it a promising target for imaging. This first-in-human study evaluates the safety and feasibility of [ 18 F]AldoView, a highly selective PET tracer targeting CYP11B2, for PA subtyping. METHODS: Biodistribution and dosimetry of [ 18 F]AldoView were assessed in 3 healthy volunteers using whole-body PET/CT. Fifteen patients with adrenal lesions (13 with PA, 1 with Cushing's syndrome, and 1 with a nonfunctional adenoma) were enrolled. PET/CT scans were performed 60 minutes postinjection. Lesions were considered positive if tracer uptake exceeded normal adrenal tissue. Semi-quantitative analyses included maximum standardized uptake value (SUVmax), lesion-to-liver ratio (LLR), and lesion-to-adrenal ratio (LAR). Ten PA patients with positive imaging findings and 1 with Cushing's syndrome underwent adrenalectomy, and resected specimens were analyzed for CYP11B2 expression. This ongoing study is registered with the Chinese Clinical Trial Registry (ChiCTR2400093214). RESULTS: [ 18 F]AldoView was well-tolerated, with no adverse events. The effective dose was 0.012±0.0022 mSv/MBq. PET/CT identified positive lesions in all 10 PA patients, with a mean SUVmax of 15.73±8.57, LAR of 8.02±4.06, and LLR of 10.24±1.48. No positive lesions were observed in patients with idiopathic hyperaldosteronism, Cushing's syndrome, or nonfunctional adenomas. Positive lesions showed strong CYP11B2 staining on pat...