Squamous Cell Carcinoma Clinical Trial
Official title:
Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins
| 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 |
| Verified date | April 2020 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| 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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