search
Back to results

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

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Imaging
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Cancer focused on measuring Skin Cancer, Non-Melanoma Skin Cancer, Optical Imaging, Multispectral Digital Microscope System, MDM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optical Imaging

Arm Description

Imaging 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.

Outcomes

Primary Outcome Measures

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 Measures

Full Information

First Posted
February 5, 2007
Last Updated
June 27, 2017
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00432471
Brief Title
Optical Imaging of Skin Cancers for Margin Delineation of Non-Melanoma Skin Cancers
Official Title
Evaluation of Optical Imaging for Margin Delineation of Non-Melanoma Skin Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 30, 2007 (Actual)
Primary Completion Date
June 25, 2017 (Actual)
Study Completion Date
June 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
All tissue and cells are made of tiny particles that give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Cancerous cells and normal cells also reflect (bounce back) light differently. Researchers want to better understand if light fluorescence and reflectance (a measure of the ability of a material to reflect sunlight) from the skin can be used to tell which cells may be cancerous. Researchers have developed the MDM system in order to better understand how cancer changes the light fluorescence and reflectance in skin. The MDM system shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area through a microscope. The pictures will then be studied to better understand the differences in fluorescence and reflectance in abnormal and normal cells. If you agree to take part in this study, an area of your skin will first be examined under standard white light. A researcher will then use the MDM imaging instrument to take pictures of abnormal-looking and normal skin areas. The researcher will mark 2-4 areas of your skin with a marker. During your surgery, you will have a small sample from a normal-looking area collected and 1 or 2 samples collected, from abnormal-looking areas of the skin. Each sample from abnormal-looking tissue will be about 3-4 millimeters wide (about the size of a small pencil eraser). After the skin lesion has been removed, but before it is needed for review by the pathologist or surgeon, the removed tissue will be examined using the MDM imaging instrument and standard white light. The edges of the removed lesion will then be examined with another type of microscope, a confocal microscope, which allows researchers to see the very small cells in the tissue. The exact location that was imaged with this microscope will be marked on the tissue, and the findings will be recorded. The tissue will then be checked by the pathologist according to standard procedures. You will not be told of any of the experimental findings. Information about the diagnosis will be available to your treating doctor. Your name and any personal identifying information (such as your name, social security number, or medical record number) will be coded to protect your privacy. This is an investigational study. Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Skin Cancer, Non-Melanoma Skin Cancer, Optical Imaging, Multispectral Digital Microscope System, MDM

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optical Imaging
Arm Type
Experimental
Arm Description
Imaging 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.
Intervention Type
Procedure
Intervention Name(s)
Optical Imaging
Intervention Description
Imaging 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.
Primary Outcome Measure Information:
Title
Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region
Time Frame
4 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. In addition, patients undergoing induction chemotherapy or biologic therapy prior to surgical resection are also eligible. Patients must sign an informed consent indicating awareness of the investigational nature of this study. Exclusion Criteria: 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. Persons who are medically unfit to undergo resection of skin lesions. Persons under the age of 18.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M. Gillenwater, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs