Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
BACKGROUND: Chinese Clinical trial registry ChiCTR2300069745, Registered 24 March 2023.
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.
CONCLUSIONS: 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.
BACKGROUND: Chinese Clinical trial registry ChiCTR2300069745, Registered 24 March 2023.
摘要：
目的：PSMA/PET已越来越多地用于检测PCa，和PSMA/PET引导活检已显示出有希望的结果。然而,无法立即确认组织是否是目标区域。在这项研究中,我们的目标是开发一种新型探测器，[123I]I-PSMA-7。首先,我们希望[123I]I-PSMA-7可以为前列腺活检提供即时确认。第二,我们希望它将有助于检测PCa。
方法：我们合成了一种高亲和力探针，[123I]I-PSMA-7，并评价其性质。我们纳入了10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。活检病变的活性通过γ-计数器测量为cpm。此外，我们招募了3例患者,以评估[123I]I-PSMA-7检测PCa的潜力.
结果：动物实验验证了安全性，[123I]I-PSMA-7的靶向性和有效性，并且在24小时时肿瘤与肌肉的比率最大，这证实了这项研究在人类身上的结果。注射185MBq[123I]I-PSMA-7后，18/55岩心呈阳性，并且cpm明显更大(4345±3547vs.714±547，P<0.001），AUC为0.97，临界值为1312（Sens/spec为94.40%/91.90%）。在较低的剂量下，10/55活检核心癌变，和cpm是2446±1622vs.153±112(P<0.001)。AUC为1,截断值为490(sens/spec为100%)。当放射性药物添加到370MBq时，我们取得了更好的SPECT/CT成像。
结论：借助[123I]I-PSMA-7并通过基于CPM的活检，我们可以将活检的数量减少到最低限度。[123I]I-PSMA-7PSMASPECT/CT也可以提供良好的成像结果。
背景：中国临床试验注册ChiCTR2300069745，注册2023年3月24日。
方法：我们合成了一种高亲和力探针，[123I]I-PSMA-7，并评价其性质。我们纳入了10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。活检病变的活性通过γ-计数器测量为cpm。此外，我们招募了3例患者,以评估[123I]I-PSMA-7检测PCa的潜力.
结果：动物实验验证了安全性，[123I]I-PSMA-7的靶向性和有效性，并且在24小时时肿瘤与肌肉的比率最大，这证实了这项研究在人类身上的结果。注射185MBq[123I]I-PSMA-7后，18/55岩心呈阳性，并且cpm明显更大(4345±3547vs.714±547，P<0.001），AUC为0.97，临界值为1312（Sens/spec为94.40%/91.90%）。在较低的剂量下，10/55活检核心癌变，和cpm是2446±1622vs.153±112(P<0.001)。AUC为1,截断值为490(sens/spec为100%)。当放射性药物添加到370MBq时，我们取得了更好的SPECT/CT成像。
结论：借助[123I]I-PSMA-7并通过基于CPM的活检，我们可以将活检的数量减少到最低限度。[123I]I-PSMA-7PSMASPECT/CT也可以提供良好的成像结果。
背景：中国临床试验注册ChiCTR2300069745，注册2023年3月24日。
