Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation
研究概览
简要总结
Primary objective :
The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.
Secondary objective:
- Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores
- Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
- Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
- Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
- Evaluate FFOCT procedure time
详细描述
Research in optical imaging has led to the development of the Full Field Optical Coherence Tomography (FFOCT) technology, which allows to image fresh tissues up to a depth of a few hundreds microns. The system is a microscope coupled with an interferometer. A halogen light source is used to illuminate the tissue specimen and a reference mirror. The light retro diffused by the specimen is combined with the light reflected by the mirror, and the interference signal is measured. Multiple Grey scale images are obtained and automatically stitched to obtain a complete slide throughout the specimen. The feasibility of the technique has been reported in various pilot studies, as well as the absence of any potential tissue harm and subsequent pathological artifact caused by the process.
FFOCT could be used as an additional detection tool for prostate cancer screening. The use of extended systematic trans-rectal ultrasound-guided (TRUS) prostate biopsies has led to over-diagnosis and over-treatment. Also, the number of unnecessary biopsies has increased, along with the morbidity of the procedure. Performing a "pre-pathological" evaluation of biopsy cores during the biopsy procedure would be of significant help to determine the nature of targeted areas and guide the number of biopsies to perform.
We hypothesize that FFOCT imaging of prostate biopsy cores would allow a cancer detection rate not statistically different from pathological analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- Patient aged 45 to 75 years old included
- •- PSA level 4.0 ng/mL
- •- Patient referred for trans rectal ultrasound-guided prostate biopsy with additional MRI-targeted biopsies
- •- Patient no opposed to participate in the study
- •Patient affiliated to the French National Social Security System
排除标准
- •Known prostate cancer
- •Patients unable to understand the course of the study
研究组 & 干预措施
Full Field Optical Coherence Tomography (FFOCT) procedure
干预措施: Full Field Optical Coherence Tomography (FFOCT) procedure (Procedure)
结局指标
主要结局
To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation
时间窗: One day (biopsy procedure)
Presence or absence of prostate cancer on pathological examination of prostate biopsy cores
次要结局
- To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores(One day (biopsy procedure))
- To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores(One day (biopsy procedure))
- To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores(One day (biopsy procedure))
- To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy(One day (biopsy procedure))
- To evaluate FFOCT procedure time(One day (biopsy procedure))