Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
NCT ID: NCT03467529
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20 participants
OBSERVATIONAL
2018-11-06
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FLT PET/CT for Staging, Target Definition and Assessment of Response to Therapy in Patients With Esophageal Cancer
NCT01243619
Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma
NCT03700398
The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer
NCT05615103
Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
NCT01401699
Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia
NCT02851264
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non interventional study
Non interventional study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Any contraindication for endoscopic treatment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emmanuel Coron, Pr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nantes University Hospital
Nantes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC16_0456
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.