The first-in-human preclinical evaluation of the new probe [123I]I-PSMA-7 for real-time intraoperative targeted biopsy and SPECT/CT imaging in prostate cancer.

IF 8.6 1区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
Xiaohui Luan, Shaoxi Niu, Yachao Liu, Xiaojun Zhang, Xiaodan Xu, Shuwei Sun, Yabing Sun, Jingfeng Zhang, Yuan Wang, Zhiqiang Chen, Yimin Chen, Mengchao Cui, Ruimin Wang, Xu Zhang, Jinming Zhang, Baixuan Xu
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引用次数: 0

Abstract

Purpose: PSMA/PET has been increasingly used to detect PCa, and PSMA/PET-guided biopsy has shown promising results. However, it cannot be confirmed immediately whether the tissues are the targeted area. In this study, we aimed to develop a novel probe, [123I]I-PSMA-7. First, we hope that [123I]I-PSMA-7 can provide instant confirmation for prostate biopsy. Second, we hope it will help detect PCa.

Methods: We synthesized a high-affinity probe, [123I]I-PSMA-7, and evaluated its properties. We included ten patients with suspected PCa and divided them into two groups. The injection and biopsy were approximately 24 h apart. The activity in biopsy lesions was measured as the cpm by a γ-counter. Moreover, we enrolled 3 patients to evaluate the potential of [123I]I-PSMA-7 for detecting PCa.

Results: Animal experiments verified the safety, targeting and effectiveness of [123I]I-PSMA-7, and the tumor-to-muscle ratio was greatest at 24 h, which confirmed the results of this study in humans. After injection of 185MBq [123I]I-PSMA-7, 18/55 cores were positive, and the cpm was significantly greater (4345 ± 3547 vs. 714 ± 547, P < 0.001), with an AUC of 0.97 and a cutoff of 1312 (sens/spec of 94.40%/91.90%). At a lower dose, 10/55 biopsy cores were cancerous, and the cpm was 2446 ± 1622 vs. 153 ± 112 (P < 0.001). The AUC was 1, with a cutoff value of 490 (sens/spec of 100%). When the radiopharmaceuticals were added to 370 MBq, we achieved better SPECT/CT imaging.

Conclusion: With the aid of [123I]I-PSMA-7 and via cpm-based biopsy, we can reduce the number of biopsies to a minimum operation. [123I]I-PSMA-7 PSMA SPECT/CT can also provide good imaging results.

Trial registration: Chinese Clinical trial registry ChiCTR2300069745, Registered 24 March 2023.

Abstract Image

首次对用于前列腺癌术中实时靶向活检和 SPECT/CT 成像的新型探针 [123I]I-PSMA-7 进行人体临床前评估。
目的:PSMA/PET 越来越多地被用于检测 PCa,PSMA/PET 指导下的活检也显示出良好的效果。然而,无法立即确认组织是否为靶区。本研究旨在开发一种新型探针--[123I]I-PSMA-7。首先,我们希望[123I]I-PSMA-7 能为前列腺活检提供即时确认。其次,我们希望它能帮助检测 PCa:方法:我们合成了一种高亲和力探针 [123I]I-PSMA-7 并对其特性进行了评估。我们纳入了十名疑似 PCa 患者,并将他们分为两组。注射和活检间隔约 24 小时。活检病灶中的活性用γ计数器测量为cpm。此外,我们还招募了3名患者,以评估[123I]I-PSMA-7检测PCa的潜力:结果:动物实验验证了[123I]I-PSMA-7的安全性、靶向性和有效性,24 h时肿瘤与肌肉的比例最大,这证实了本研究在人体中的结果。注射 185MBq [123I]I-PSMA-7 后,18/55 个核芯呈阳性,且 cpm 显著增大(4345 ± 3547 vs. 714 ± 547,P 结论:[123I]I-PSMA-7 对肿瘤的靶向性和有效性具有显著优势:借助[123I]I-PSMA-7和基于cpm的活检,我们可以将活检次数减少到最低限度。[123I]I-PSMA-7 PSMA SPECT/CT 也能提供良好的成像效果:试验注册:中国临床试验注册中心 ChiCTR2300069745,注册日期:2023年3月24日。
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来源期刊
CiteScore
15.60
自引率
9.90%
发文量
392
审稿时长
3 months
期刊介绍: The European Journal of Nuclear Medicine and Molecular Imaging serves as a platform for the exchange of clinical and scientific information within nuclear medicine and related professions. It welcomes international submissions from professionals involved in the functional, metabolic, and molecular investigation of diseases. The journal's coverage spans physics, dosimetry, radiation biology, radiochemistry, and pharmacy, providing high-quality peer review by experts in the field. Known for highly cited and downloaded articles, it ensures global visibility for research work and is part of the EJNMMI journal family.
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