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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02507141
Enrollment
140
Registered
2015-07-23
Start date
2015-07-21
Completion date
2026-07-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Squamous Cell Carcinoma (SCC) of the Oral Cavity

Keywords

Reflectance Confocal Microscopy, 15-128

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.

Interventions

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reflectance Confocal Microscopy (RCM) images1 yearEach 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.

Countries

United States

Contacts

CONTACTSnehal Patel, MD
212-639-3412
CONTACTMilind Rajadhyaksha, PhD
646-888-6243
PRINCIPAL_INVESTIGATORSnehal Patel, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026