Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Study schedule Total length of study: 24 months Methodology and regulatory: 6 months Recruitment period: 1 year Recruitment among the patients scheduled for the endoscopic procedure in the operative room One single visit = inclusion the day of the procedure No follow-up required Analyses: 3 months Paper writing: 3 months

Official Title
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Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Other: Non interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnancy Any contraindication for endoscopic treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non interventional study|Non interventional study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology | 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. | Immediately after endoscopic resection (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial esophageal cancer, Squamous cell cancer, Mini invasive imaging, Pre therapeutic assessment, Optical coherence tomography