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

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ClinicalTrials.gov Identifier: NCT02507141
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Squamous Cell Carcinoma (SCC) of the Oral Cavity Device: Reflectance Confocal Microscopy

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
Actual Study Start Date : July 21, 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Group/Cohort Intervention/treatment
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.
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 :
  1. Reflectance Confocal Microscopy (RCM) images [ Time Frame: 1 year ]
    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.


Biospecimen Retention:   Samples Without DNA
Samples of tissue from tumor and margin


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507141


Contacts
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Contact: Snehal Patel, MD 212-639-3412
Contact: Milind Rajadhyaksha, PhD 646-888-6243

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Snehal Patel, MD    212-639-3412      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Snehal Patel, MD    212-639-3412      
United States, New York
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Snehal Patel, MD    212-639-3412      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Snehal Patel, MD    212-639-3412      
Contact: Milind Rajadhyaksha, PhD    646-888-6243      
Principal Investigator: Snehal Patel, MD         
Memorial Sloan Kettering @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Snehal Patel, MD    212-639-3412      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Snehal Patel, MD    212-639-3412      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Snehal Patel, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02507141     History of Changes
Other Study ID Numbers: 15-128
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Reflectance Confocal Microscopy
15-128

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases