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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Potential research subjects in the Head and Neck Service will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan Kettering Cancer Center (MSK).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Reflectance Confocal Microscopy

    Device

    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.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: SCC of the oral cavity scheduled for surgery1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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