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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507141
• Other study ID #: 15-128
• Status: Recruiting
• Start date: July 21, 2015
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Snehal Patel, MD
• Phone: 212-639-3412
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Mouth Neoplasms
• Squamous Cell Carcinoma (SCC) of the Oral Cavity

Intervention

Device:
• Reflectance Confocal Microscopy
Reflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (consent only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering West Harrison (consent only)	Harrison	New York
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 Nassau (consent only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflectance Confocal Microscopy (RCM) images	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center