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NCT02507141 · ClinicalTrials.gov registry record
Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
A clinical trial of Head and Neck Cancer and Squamous Cell Carcinoma (SCC) of the Oral Cavity, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- 140
- Enrollment target
- 5
- Study locations
NCT02507141: Recruiting study of Head and Neck Cancer and Squamous Cell Carcinoma (SCC) of the Oral Cavity, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02507141 is a study of Head and Neck Cancer and Squamous Cell Carcinoma (SCC) of the Oral Cavity that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 140 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (46% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02507141, a study of Head and Neck Cancer and Squamous Cell Carcinoma (SCC) of the Oral Cavity, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- 140 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
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 image
Conditions Studied
Interventions
- DEVICE Reflectance Confocal Microscopy
Study Locations (5)
New York
- Memorial Sloan Kettering West Harrison (consent only) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (consent only) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (consent only) - Basking Ridge
- Memorial Sloan Kettering Monmouth (consent only) - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2026-07 |
What NCT02507141 shows while recruiting
NCT02507141 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (46% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Reflectance Confocal Microscopy is the first listed.
NCT02507141 lists 5 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02507141 about?
NCT02507141 is a clinical study titled "Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology". 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 tiss...
What is the current status of trial NCT02507141?
This trial is currently recruiting. The enrollment target is 140 participants. The study started on 2015-07-21. Estimated completion is 2026-07.
What conditions does trial NCT02507141 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Squamous Cell Carcinoma (SCC) of the Oral Cavity.
What interventions are being tested in trial NCT02507141?
The interventions under investigation include: Reflectance Confocal Microscopy (DEVICE).
Who is sponsoring clinical trial NCT02507141?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02507141 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02507141's enrollment target sits among peer trials
140 66th of 250 higher than 185 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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