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

February 6, 2024 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

10 patients will be recruited by the Clinical investigation center by reviewing the scheduled SCC resections each week. All patients scheduled for an endoscopic resection of SCC will be considered for inclusion in the study. The study itself will take place in the department of gastroenterology. Recruitment within one year of inclusion will be possible because our unit is a regional reference center for interventional endoscopy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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
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.
Immediately after endoscopic resection (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Emmanuel Coron, Pr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC16_0456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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