Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins

Completed

• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma

• Registration Number: NCT01872130
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-07
• Status Verified: 2020-04
• Primary Completion: 2020-04-28
• Study Completion: 2020-04-28
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients undergoing Mohs surgery for basal cell carcinoma (BCC )or squamous cell carcinoma (SCC). .
• Ability to sign informed consent.
• Age ≥ 18 years.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
test feasibility of a mosaicing algorithm intraoperative	1 year	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).

Secondary Outcome Measures

Name	Time	Method
test feasibility of a mosaicing algorithm preoperative	1 year	imaging of cancer margins on patients, before Mohs surgery.

Trial Locations

Locations (4)

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center Hauppauge; 🇺🇸 Hauppauge, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States