Optical Imaging of Skin Cancers for Margin Delineation of Non-Melanoma Skin Cancers
Evaluation of Optical Imaging for Margin Delineation of Non-Melanoma Skin Cancers
3 other identifiers
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2007
CompletedFirst Submitted
Initial submission to the registry
February 5, 2007
CompletedFirst Posted
Study publicly available on registry
February 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2017
CompletedJune 28, 2017
June 1, 2017
10.4 years
February 5, 2007
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region
4 Years
Study Arms (1)
Optical Imaging
EXPERIMENTALImaging 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann M. Gillenwater, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2007
First Posted
February 7, 2007
Study Start
January 30, 2007
Primary Completion
June 25, 2017
Study Completion
June 25, 2017
Last Updated
June 28, 2017
Record last verified: 2017-06