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

NCT03467529 | Completed

• 1 other identifier: RC16_0456
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer

Keywords

Superficial esophageal cancer; Squamous cell cancer; Mini invasive imaging; Pre therapeutic assessment; Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Non interventional study OTHER

Non interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Any contraindication for endoscopic treatment

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasms, Squamous Cell

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Emmanuel Coron, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: March 16, 2018
• Study Start: November 6, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)