Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology
研究概览
简要总结
New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (SCC) in order to improve outcomes of this frequent and lethal cancer.
Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3D reconstruction. This device has never been tested on esophageal specimens.
Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in SCC.
To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device and we will compare the results with histological analysis of these specimens.
详细描述
General study methodology
The study presents the following characteristics:
- Observational
- Non interventional imaging study
- Single-centre
- Not controlled
- Prospective Tests and analysis CRF
- Filled by the investigator
- Data from the medical file of the patient Imaging
- As standard of care
- Before endoscopic resection the lesion will be characterized and pictures will be made using white light endoscopy, magnification techniques and electronic chromoendoscopy
- Immediately after endoscopic resection, the specimen will be prepared, oriented and scanned using the FFOCT device (CE marking)
- Imaging movies will be then reviewed by trained readers and compared to movies of healthy patients, findings will be described
- Imaging movies will be compared to pathology slides
Pathology
- After scanning the specimen will be sent to pathology for analysis
- The pathology slides will be scanned to be kept in the study record together with their interpretation
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years and more
- •Confirmed diagnosis of SCC based on previous biopsy
- •Indication for endoscopic resection
- •Patient who has read the information notice and confirmed its willing to participate
排除标准
- •Pregnancy
- •Any contraindication for endoscopic treatment
结局指标
主要结局
Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology
时间窗: Immediately after endoscopic resection (Day 0)
The principal objective of this study will be reached if: * the tumoral lesion is correctly identified in the specimen in FFOCT images * and/or the normal esophageal mucosa and submucosal and/or normal vessels are correctly identified in the specimen in FFOCT images * in at least 8 specimens.
次要结局
未报告次要终点