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

NCT ID: NCT02507141

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-21

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SCC of the oral cavity scheduled for surgery

The patients will be imaged for testing the feasibility of intra-oral imaging. Images will be compared to and evaluated against the corresponding pathology that is routinely prepared during surgery.

Reflectance Confocal Microscopy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Snehal Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan Kettering Basking Ridge (consent only)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (consent only)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering West Harrison (consent only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (consent only)

Uniondale, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Snehal Patel, MD

Role: CONTACT

212-639-3412

Milind Rajadhyaksha, PhD

Role: CONTACT

646-888-6243

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Snehal Patel, MD

Role: primary

212-639-3412

Snehal Patel, MD

Role: primary

212-639-3412

Snehal Patel, MD

Role: primary

212-639-3412

Snehal Patel, MD

Role: primary

212-639-3412

Milind Rajadhyaksha, PhD

Role: backup

646-888-6243

Snehal Patel, MD

Role: primary

212-639-3412

Related Links

Access external resources that provide additional context or updates about the study.

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-128

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.