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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01872130

Enrollment

Registered

2013-06-07

Start date

2013-05-31

Completion date

2020-04-28

Last updated

2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma, Squamous Cell Carcinoma

Keywords

Moh's Surgery, mosaicing algorithm, intraoperative imaging, 12-239

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results