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

Last updated: March 11, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Human Papilloma Virus (Hpv)

Head And Neck Cancer

Nasopharyngeal Cancer

Treatment

Reflectance Confocal Microscopy

Clinical Study ID

NCT02507141
15-128
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSKHead and Neck Service.

  • Ability to sign informed consent.

  • Age ≥ 18 years.

Exclusion

Exclusion Criteria:

  • Cancer located on a site that may not be convenient or accessible for imaging withthe current version of the RCM device (gingivobuccal region, back of the oralcavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).

  • Inability to give informed consent.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Reflectance Confocal Microscopy
Phase:
Study Start date:
July 21, 2015
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (consent only)

    Basking Ridge, New Jersey
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (consent only)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memoral Sloan Kettering West Harrison (consent only)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering West Harrison (consent only)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering @ Rockville

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (consent only)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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