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Skin Cancer | Optical Imaging of Skin Cancers for Margin Delineation of Non-Melanoma Skin Cancers

Skin Cancer research study

What is the primary objective of this study?

The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Researchers want to learn if this new technology can help doctors identify the exact areas involved in precancerous or cancerous changes in the skin.

Who is eligible to participate?

Inclusion Criteria: 1. Patients who will be undergoing surgery to remove a region of skin suspected of containing non-melanoma skin cancer will be eligible to participate in this study. The proposed resection should be equal or greater than 1 cm in diameter. 2. In addition, patients undergoing induction chemotherapy or biologic therapy prior to surgical resection are also eligible. 3. Patients must sign an informed consent indicating awareness of the investigational nature of this study. Exclusion Criteria: 1. Patients with non-melanoma skin cancer lesion at eyelid, or in case that the lesion extends to superior or inferior eyelid, this area will not be imaged. 2. Persons who are medically unfit to undergo resection of skin lesions. 3. Persons under the age of 18.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Skin Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Optical ImagingImaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Optical ImagingImaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.

Study Status

Completed

Start Date: January 30, 2007

Completed Date: June 25, 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ann M. Gillenwater, MD

Lead Sponsor: M.D. Anderson Cancer Center

Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)

More information:https://clinicaltrials.gov/show/NCT00432471

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