Development of an Intraoperative Adaptive Biopsy System for Prostate Cancer: Integrating Imaging Navigation With Metabolic Feedback for Dynamic Decision-Making
An MRI-Based Diagnostic Model for Prostate Cancer Localization: An Exploratory Study Integrating Radiomics and the Metabolic Microenvironment
Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
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-
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Shanghai、中国
- 招聘中
- Shanghai Geriatric Medical Center
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接触：
- Shanghai Geriatric Medical Center
- 电话号码：+86 51371990
- 邮箱：zsurology@126.com
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Shanghai、中国
- 招聘中
- Zhongshan Hospital, Fudan University
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接触：
- Zhongshan Hospital, Fudan University
- 电话号码：+86 64041990
- 邮箱：wang.hang@zs-hospital.sh.cn
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Shanghai、中国
- 招聘中
- Minhang Hospital, Fudan University
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接触：
- Minhang Hospital, Fudan University
- 电话号码：+86 64923400
- 邮箱：zsyhuangjq@163.com
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Shanghai、中国
- 招聘中
- Xuhui Hospital, Fudan University
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接触：
- Xuhui Hospital, Fudan University
- 电话号码：+86 36682220
- 邮箱：wang.hang@zs-hospital.sh.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients who underwent prostate biopsy at three medical centers in Shanghai: Minhang Hospital, Fudan University; Xuhui Hospital, Fudan University and Shanghai Geriatric Medical Center
描述
Inclusion Criteria:
- Age ≥55 years;
- Indication for prostate biopsy;
- Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.
Exclusion Criteria:
- Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
- Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
- Cachexia or organ function decompensation.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
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Adaptive Biopsy Group
Adaptive dynamic biopsy is performed using an intelligent system integrating preoperative imaging data with real-time intraoperative metabolic feedback. |
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Systemic Biopsy Group
A 10-12-core systematic biopsy. |
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mpMRI Fusion Targeted Biopsy Group
mpMRI-US fusion-guided targeted prostate biopsy |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group
大体时间：After 8 weeks of the enrollment process was completed
|
After 8 weeks of the enrollment process was completed
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Prostate cancer detection rate
大体时间：After 8 weeks of the enrollment process was completed
|
After 8 weeks of the enrollment process was completed
|
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Missed diagnosis rates in the adaptive biopsy group and the mpMRI-US fusion-targeted biopsy group
大体时间：After 8 weeks of the enrollment process was completed
|
After 8 weeks of the enrollment process was completed
|
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The time of biopsy
大体时间：After 8 weeks of the enrollment process was completed
|
After 8 weeks of the enrollment process was completed
|
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Complication rate
大体时间：After 8 weeks of the enrollment process was completed
|
After 8 weeks of the enrollment process was completed
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.