NCT02185170终止不适用
Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Complete fluorescence measurement over each field of vision.
研究概览
简要总结
The aim of this study is divided in 4 different steps:
- the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
- the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,
- the third step is to validate the use of:
- the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
- the Light-CT scanner use for tissue structural observation.
- the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Male patient over 18 years old.
- •Patient scheduled for trans-urethral resection of prostate with:
- •prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age > 80 years old
- •a suspected prostate cancer after a digital rectal examination (DRE) and a PSA blood level > 50 ng/ml or an existing prostate cancer
- •Patient affiliated to social security or beneficiary of such a regime.
排除标准
- •Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health
研究组 & 干预措施
Fluorescence assesment
Experimental
All patients undergo a transurethral resection.
There are four different steps in the study:
- the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,
- the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,
- the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,
- the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner.
干预措施: Trans-urethral resection (Procedure)
Fluorescence assesment
Experimental
All patients undergo a transurethral resection.
There are four different steps in the study:
- the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,
- the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,
- the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,
- the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner.
干预措施: Use of the FEMTO-ST institute medical device (Device)
Fluorescence assesment
Experimental
All patients undergo a transurethral resection.
There are four different steps in the study:
- the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,
- the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,
- the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,
- the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner.
干预措施: Use of the Light-CT scanner (Device)
结局指标
主要结局
Complete fluorescence measurement over each field of vision.
时间窗: 1 day
Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.
次要结局
- Complete fluorescence measurement over each field of vision.(1 day)
- Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides(1 day)
- Quality criteria of the structure of tissue (ordinal qualitative variables).(1 day)
- Fluorescence measurements mean.(1 day)
研究者
研究点 (1)
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