Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins
1 other identifier
observational
45
1 country
4
Brief Summary
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal microscope to determine whether this technique may be useful in the future for helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter surgery and improved care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 31, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2020
CompletedMay 1, 2020
April 1, 2020
7 years
May 31, 2013
April 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
test feasibility of a mosaicing algorithm intraoperative
For the primary study objective, the Mohs surgeon will perform a qualitative assessment of the confocal mosaic. This will be a dichotomous assessment of whether the mosaic is of sufficient quality (contrast and resolution) to identify individual features. The specific features for BCC or SCC margins are tumor nests with nuclear atypia and increased nuclear density (relative to the density seen in normal basal cells).
1 year
Secondary Outcomes (1)
test feasibility of a mosaicing algorithm preoperative
1 year
Eligibility Criteria
Patients in Dermatology clinics at MSKCC
You may qualify if:
- Patients undergoing Mohs surgery for basal cell carcinoma (BCC )or squamous cell carcinoma (SCC). .
- Ability to sign informed consent.
- Age ≥ 18 years.
You may not qualify if:
- Mohs surgery located on a site that may not be convenient to confocal imaging.
- Inability to give informed consent.
- Inability to tolerate imaging procedure (i.e., remain relatively still for multiple short durations of 3-4 minutes) over a total time of 20 minutes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center Hauppauge
Hauppauge, New York, 11788, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kishwer Nehal, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2013
First Posted
June 7, 2013
Study Start
May 1, 2013
Primary Completion
April 28, 2020
Study Completion
April 28, 2020
Last Updated
May 1, 2020
Record last verified: 2020-04