NCT07690462尚未招募不适用
A Clinical Validation Study of Novel Infrared Fluorescence Rapid Staining Versus Conventional Frozen Section in Intraoperative Diagnosis of Prostate Cancer
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of prostate biopsy specimens
研究概览
简要总结
This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •All adult male patients who are scheduled to undergo prostate biopsy at the Department of Urology, Xiangya Hospital due to clinical suspicion (e.g., elevated PSA, abnormal digital rectal examination, or suspicious lesions on imaging).
- •Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure.
- •The patient or their legally authorized representative has signed the written informed consent form.
排除标准
- •Patients in the acute infection phase or febrile period.
- •Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
- •Patients with any serious concomitant disease that, in the investigator's opinion, may interfere with the study results or increase the patient's risk (e.g., hypertensive crisis; decompensated cardiac insufficiency; severe internal or external hemorrhoids, perianal or rectal lesions, etc.).
结局指标
主要结局
Diagnostic accuracy of prostate biopsy specimens
时间窗: At baseline (Single visit)
To evaluate the diagnostic accuracy of the novel rapid infrared fluorescence staining technique for prostate biopsy specimens, and to compare it with frozen section.
次要结局
未报告次要终点
研究者
研究点 (1)
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