{"title":"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。","authors":"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","doi":"10.1007/s00259-024-06833-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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, [<sup>123</sup>I]I-PSMA-7. First, we hope that [<sup>123</sup>I]I-PSMA-7 can provide instant confirmation for prostate biopsy. Second, we hope it will help detect PCa.</p><p><strong>Methods: </strong>We synthesized a high-affinity probe, [<sup>123</sup>I]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 [<sup>123</sup>I]I-PSMA-7 for detecting PCa.</p><p><strong>Results: </strong>Animal experiments verified the safety, targeting and effectiveness of [<sup>123</sup>I]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 [<sup>123</sup>I]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.</p><p><strong>Conclusion: </strong>With the aid of [<sup>123</sup>I]I-PSMA-7 and via cpm-based biopsy, we can reduce the number of biopsies to a minimum operation. [<sup>123</sup>I]I-PSMA-7 PSMA SPECT/CT can also provide good imaging results.</p><p><strong>Trial registration: </strong>Chinese Clinical trial registry ChiCTR2300069745, Registered 24 March 2023.</p>","PeriodicalId":11909,"journal":{"name":"European Journal of Nuclear Medicine and Molecular Imaging","volume":null,"pages":null},"PeriodicalIF":8.6000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11527917/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"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\",\"doi\":\"10.1007/s00259-024-06833-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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, [<sup>123</sup>I]I-PSMA-7. First, we hope that [<sup>123</sup>I]I-PSMA-7 can provide instant confirmation for prostate biopsy. Second, we hope it will help detect PCa.</p><p><strong>Methods: </strong>We synthesized a high-affinity probe, [<sup>123</sup>I]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 [<sup>123</sup>I]I-PSMA-7 for detecting PCa.</p><p><strong>Results: </strong>Animal experiments verified the safety, targeting and effectiveness of [<sup>123</sup>I]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 [<sup>123</sup>I]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.</p><p><strong>Conclusion: </strong>With the aid of [<sup>123</sup>I]I-PSMA-7 and via cpm-based biopsy, we can reduce the number of biopsies to a minimum operation. [<sup>123</sup>I]I-PSMA-7 PSMA SPECT/CT can also provide good imaging results.</p><p><strong>Trial registration: </strong>Chinese Clinical trial registry ChiCTR2300069745, Registered 24 March 2023.</p>\",\"PeriodicalId\":11909,\"journal\":{\"name\":\"European Journal of Nuclear Medicine and Molecular Imaging\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":8.6000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11527917/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Nuclear Medicine and Molecular Imaging\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00259-024-06833-4\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Nuclear Medicine and Molecular Imaging","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00259-024-06833-4","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/23 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
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.
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.
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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