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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03467529

Collaborator

(none)

Enrollment

Location

47.8

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophagus Cancer	Other: Non interventional study

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 6, 2018

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Outcome Measures

Primary Outcome Measures

Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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