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

Esophagus Cancer Clinical Trial

— OESOCiTy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467529
• Other study ID #: RC16_0456
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Other:
• Non interventional study
Non interventional study

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)