Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer: A Prospective, Single Center and Paired-design Diagnostic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.
研究概览
简要总结
The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are:
- Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer.
- Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer.
The data of participants was collected prospectively.
详细描述
The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination, serum prostate-specific antigen detection, transrectal prostate ultrasound, and multi-parameter magnetic resonance imaging. However, these methods lack sufficient specificity for the diagnosis of prostate cancer. Therefore, prostate biopsy is still the gold standard for the diagnosis of prostate cancer. mpMRI has good accuracy in detecting clinically significant prostate cancer, but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm, and false positive results may occur for benign diseases such as prostatitis. The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 1.5T or 3.0T. The application of 3.0T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer, making it the most commonly used magnetic field strength for mpMRI. The main problems of 3.0T prostate magnetic resonance examinations are low specificity (false positive results) and insufficient accuracy in determining tumor staging. At present, there is no research and exploration on the use of 5.0T magnetic resonance in the diagnosis of prostate cancer in the world. This study intends to analyze and compare the differences between 5.0TbpMRI and 3.0TbpMRI in the diagnosis of prostate cancer through a prospective, paired-design diagnostic trial, and try to explore whether 5.0TbpMRI can improve the limitations of 3.0TbpMRI in the diagnosis of prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) );
- •The primary prostate cancer has no other cancer history;
- •The 3.0TbpMRI examination was completed, and the images were clear and accessible;
- •The 5.0TbpMRI examination was further completed, and the images were clear and accessible;
- •The patient fully understands the relevant content of the study and voluntarily signs the informed consent.
排除标准
- •The patient has contraindications to MRI examination, such as metal plates and heart stents in the body;
- •The patient does not have an indication for prostate biopsy or refuses biopsy;
- •The patient has contraindications to prostate biopsy;
- •3.0T MRI considers that the patient has multiple lymph node or bone metastases;
- •The patient has undergone other prostatic surgery in the past;
- •The patient is unable to cooperate, has communication barriers, or refuses to sign the informed consent form.
结局指标
主要结局
Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.
时间窗: through study completion, an average of 1 month
Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.
次要结局
- Evaluation of the reliability (repeatability) of the diagnostic test.(through study completion, an average of 1 month)
- Comparative analysis of the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the stage of prostate cancer(through study completion, an average of 2 months)
研究者
XiaoJun
Professor, Chief Physician
Anhui Provincial Hospital