Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reflectance Confocal Microscopy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Squamous Cell Carcinoma (SCC) of the Oral Cavity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Reflectance Confocal Microscopy (RCM) images [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Memorial Sloan Kettering Basking Ridge (consent only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (consent only) — Middletown
- Memorial Sloan Kettering West Harrison (consent only) — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau (consent only) — Uniondale
Identifiers
NCT: NCT02507141 · 15-128