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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01872130
Other study ID # 12-239
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date April 28, 2020

Study information

Verified date April 2020
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date April 28, 2020
Est. primary completion date April 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
United States 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

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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