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

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.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

Non interventional study

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: OESOCiTy

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Mar 16, 2018
Registry last updated: Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed