Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 464
- 主要终点
- Positive rate of ultrasound radiomics fusion targeted biopsy
研究概览
简要总结
To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.
详细描述
Researchers plan to develop a diagnostic and prognostic evaluation model for prostate cancer by analyzing abnormal echoes in prostate ultrasound images through radiomics. This model will be used to guide ultrasound radiomics-fusion prostate biopsy, and its accuracy will be compared with that of systematic biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥55 years old.
- •Patients had tPSA/fPSA within 1 month before biopsy.
- •Patients had any of the following indications for prostate biopsy:
- •Suspicious prostate nodules were found by digital rectal examination
- •Suspicious lesions were detected by B-ultrasound or MRI
- •PSA>10ng/ml
- •PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values
排除标准
- •malignant tumors other than prostate adenocarcinoma indicated by pathology.
- •Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
- •Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc
结局指标
主要结局
Positive rate of ultrasound radiomics fusion targeted biopsy
时间窗: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of ultrasound radiomics fusion targeted biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy
时间窗: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy
Ultrasound radiomics parameters
时间窗: The 30min following the transrectal ultrasonography
The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.
次要结局
- PI-RADS score(Within one month prior to prostate biopsy.)
- tPSA and fPSA(Within one month prior to prostate biopsy.)
- Gleason's score of positive tissue(Up to seventh day when the pathological results were obtained after the targeted biopsy)
- Prostate tumor capsular invasion and positive surgical margin(Up to seventh day after radical prostatectomy.)
- Incidence of complications(Up to the first month after the targeted biopsy)
研究者
Chang He
Associate Clinical Professor
Shanghai Minhang Central Hospital