最近于2024年7月进行的64Cu-SAR-bisPSMA PET扫描显示,尽管患者自2023年6月最后一次服用67Cu-SAR-bisPSMA后约14个月未接受任何67Cu-SAR-bisPSMA治疗,但肿瘤体积与基线相比减少了41.6%(图1)。 图1所示. 图像显示,在4次67Cu-SAR-bisPSMA(每次4GBq)剂量后,病变摄取(64Cu-SAR-bisPSMA PET)显著减少;PET于2024...
64Cu-SAR-bisPSMA 获得 FDA 晚期前列腺癌成像快速通道资格。FDA 已授予 Clarity Pharmaceuticals 的 64Cu-SAR-bisPSMA 快速通道资格,这是一种新型成像剂,用于对疑似转移的前列腺特异性膜抗原 (PSMA) 阳性前列腺癌病变进行正电子发射断层扫描 (PET) 成像。据该公司称,该药物得到了有希望的临床结果的支持,已证明优...
FDA快速审批64Cu-SAR-bisPSMA用于前列腺癌成像 64Cu-SAR-bisPSMA 获得 FDA 晚期前列腺癌成像快速通道资格。 FDA 已授予 Clarity Pharmaceuticals 的 64Cu-SAR-bisPSMA 快速通道资格,这是一种新型成像剂,用于对疑似转移的前列腺特异性膜抗原 (PSMA) 阳性前列腺癌病变进行正电子发射断层扫描 (PET) 成像。据该公司称...
“我们已完成的PROPELLER试验的阳性结果表明,64Cu-SAR-bisPSMA是安全的,并且与澳大利亚和美国批准的前列腺癌标准护理PSMA显像剂相比,64Cu-SAR-bisPSMA在表达PSMA的癌症病变中的摄取显著较高。这可能使我们在PROPELLER试验中观察到更多和更小的病变的诊断成为可能,我们...
The FDA has granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions.
Clarity Pharmaceuticals and PSI CRO AG have entered into an agreement and have commenced work towards Clarity's Phase III diagnostic trial of SAR-bisPSMA in prostate cancer participants, CLARIFY 1.
Eligible patients will receive a single administration of64Cu-SAR-bisPSMA (200 MBq) followed by a PET/CT scan on Day 1 (1-4 hours post-dose) and on Day 2 (24卤6 hours post-dose). Patients will proceed to RP with PLND. The specimens from surgery will be processed and analyzed ...
64Cu-SAR-bisPSMA 获得 FDA 晚期前列腺癌成像快速通道资格。 FDA 已授予 Clarity Pharmaceuticals 的 64Cu-SAR-bisPSMA 快速通道资格,这是一种新型成像剂,用于对疑似转移的前列腺特异性膜抗原 (PSMA) 阳性前列腺癌病变进行正电子发射断层扫描 (PET) 成像。据该公司称,该药物得到了有希望的临床结果的支持,已证明优...
Clinical/translational evidence has demonstrated higher tumor uptake (2-3x), prolonged retention and detection of additional PC lesions using64Cu-SAR-bisPSMA compared to approved PSMA agents.Methods:This was a phase I/II study assessing the safety and efficacy of64Cu-SAR-bisPSMA (200 MBq) in ...
These results led to the development of this clinical study, which aims to assess safety and anti-tumor efficacy of67Cu-SAR-bisPSMA in patients with metastatic castrate resistant PC (mCRPC).Methods:SECuRE is a phase I/IIa multi-center, open-label, non-randomized, dose-escalation and cohort ...