NCT03157856终止不适用
Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).
研究概览
简要总结
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:
- / the FEMTO-ST institute medical device,
- / the confocal microscope that will be used to measure fluorescence spectra of biological samples.
详细描述
For this protocol, 12 patients will be included.
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
- 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 with indication for radical prostatectomy
- •patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.
- •patient affiliated to French social security system or equivalent
- •patient who have signed a non-opposition form
排除标准
- •patient with contraindication to radical prostatectomy
- •patient with remedial prostatectomy
- •patient with normal preoperative MRI or with absence of tumoral area
- •patient with history of hormonal therapy
- •person deprived of freedom by judicial or administrative decision
- •person under legal protection
- •person hospitalized for psychiatric care.
结局指标
主要结局
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).
时间窗: 14 months
Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.
次要结局
- Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).(14 months)
研究者
研究点 (2)
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