NCT04967001招募中不适用
Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT
研究概览
简要总结
Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial.
To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND
- •ISUP Gleason grade group ≥ 4
排除标准
- •Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases
- •General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
- •Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
- •Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
结局指标
主要结局
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT
时间窗: 2 years
To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PET/CT to that of the current standard multiparametric MRI, using histopathology as the gold standard.
次要结局
未报告次要终点
研究者
Qin Weijun
Professor and Director, Department of Urology
Xijing Hospital
研究点 (1)
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