Clinical trial NCT03467529: Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
Official title: Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Cancer
Keywords: Superficial esophageal cancer
Squamous cell cancer
Mini invasive imaging
Pre therapeutic assessment
Optical coherence tomography
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology
timeFrame: Immediately after endoscopic resection (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Emmanuel Coron, Pr
role: PRINCIPAL_INVESTIGATOR
References: