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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01872130

Collaborator

(none)

Enrollment

Locations

83.9

Duration (Months)

11.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma Squamous Cell Carcinoma

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Apr 28, 2020

Actual Study Completion Date :

Apr 28, 2020

Outcome Measures

Primary Outcome Measures

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

test feasibility of a mosaicing algorithm preoperative [1 year]
imaging of cancer margins on patients, before Mohs surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering West Harrison	Harrison	New York	United States	10604
3	Memorial Sloan Kettering Cancer Center Hauppauge	Hauppauge	New York	United States	11788
4	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065