[Translation] A phase III, open-label, multicenter clinical trial to evaluate the diagnostic efficacy of 18F-fluorinated sirolimus injection PET/CT imaging in detecting pelvic lymph node metastases in patients undergoing radical surgery for prostate cancer.
主要目的:
1. 评价氟[18F]思睿肽注射液 PET/CT 成像检测拟接受前列腺癌根治性手术的患者是否存在盆腔淋巴结转移的诊断效能
次要目的:
1. 评价氟[18F]思睿肽注射液 PET/CT 成像在中国受试者中的安全性
2. 评价与常规影像相比, 氟[18F]思睿肽注射液 PET/CT 成像对病灶(淋巴结、 骨、 软组织转移灶) 的检出率
3. 评价独立阅片人 PET 图像的阅片稳定性
探索性目的:
1. 评价氟[18F]思睿肽注射液在病灶区域内(骨、 淋巴结、 软组织、 前列腺) 的摄取
2. 评价氟[18F]思睿肽注射液在前列腺及前列腺外病灶的摄取与基线PSA 水平以及行根治术时 Gleason 评分的关系
[Translation] Primary objectives:
1. To evaluate the diagnostic efficacy of fluorine [18F] sirolimus injection PET/CT imaging for the detection of pelvic lymph node metastasis in patients who are scheduled to undergo radical prostatectomy
Secondary objectives:
1. To evaluate the safety of fluorine [18F] sirolimus injection PET/CT imaging in Chinese subjects
2. To evaluate the detection rate of fluorine [18F] sirolimus injection PET/CT imaging for lesions (lymph nodes, bones, and soft tissue metastases) compared with conventional imaging
3. To evaluate the stability of PET images read by independent readers
Exploratory objectives:
1. To evaluate the uptake of fluorine [18F] sirolimus injection in the lesion area (bone, lymph nodes, soft tissue, prostate)
2. To evaluate the relationship between the uptake of fluorine [18F] sirolimus injection in the prostate and extraprostatic lesions and the baseline PSA level and the Gleason score at the time of radical surgery