NCT03467529

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
OTHER	Non interventional study	Non interventional study

Timeline

• Start date: 2018-11-06
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2018-03-16
• Last updated: 2024-02-08

Locations

1 site across 1 country: France