Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology

Recruiting

• Conditions: Head and Neck Cancer; Squamous Cell Carcinoma (SCC) of the Oral Cavity
• Interventions: Device: Reflectance Confocal Microscopy

• Registration Number: NCT02507141
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-21
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.
• Ability to sign informed consent.
• Age ≥ 18 years.

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Exclusion Criteria

• Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).
• Inability to give informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SCC of the oral cavity scheduled for surgery	Reflectance Confocal Microscopy	The patients will be imaged for testing the feasibility of intra-oral imaging. Images will be compared to and evaluated against the corresponding pathology that is routinely prepared during surgery.

Primary Outcome Measures

Name	Time	Method
Reflectance Confocal Microscopy (RCM) images	1 year	Each set of images and the corresponding pathology will be evaluated by the study pathologist for the presence or absence of oral SCC. All images will be evaluated as a group. First, the pathologist will review the RCM images for each imaging site and will determine the presence/absence of tumor. Next, the pathologist will review the corresponding histopathologic material for the presence/absence of tumor. If there is discordance in the evaluations, the pathologist will re-evaluate the RCM images with the corresponding pathology, in a side-by-side manner, to highlight any features that may assist in the RCM evaluation.

Trial Locations

Locations (5)

Memorial Sloan Kettering Basking Ridge (consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering West Harrison (consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (consent only); 🇺🇸 Uniondale, New York, United States