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Study Summary
No. 2006-0493:.......Skin......Ann M. Gillenwater......Head/Neck Surgery
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Study Summary Title
Study Summary
Number:
2006-0493
Study Title:Evaluation of Optical Imaging for Margin Delineation of Non-melanoma Skin Cancers
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Physician New Patient Referral
Name:Ann M. GillenwaterPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Head/Neck SurgeryReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6520
Contact us about clinical trials
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General Information
Disease Group:SkinSupported By:N/A
Phase of Study:N/AReturn
Visit:
This study requires a one-time intervention with the subject.
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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.
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Study Objectives / Outcomes
    The primary objective of this exploratory laboratory study is to evaluate the ability of optical imaging technologies such as and fluorescence and reflectance imaging and confocal microscopy to assist in margin detection during surgical resections of non-melanoma skin cancers. We hypothesize that these optical imaging technologies may help surgeons delineate the precise areas involved in cancerous or precancerous changes in the skin at the time of surgery; this should directly impact the quality of patient care by facilitating complete tumor removal, while allowing sparing of more un-involved, normal skin.

    The secondary objectives of this study are:
· To compare cutaneous lesion fluorescence images and spectra, obtained at several specific excitation wavelengths (including 350 nm, 380 nm, 405 nm, and/or 450 nm excitation), to standard white light images and pathologic analysis of biopsied tissue.
· To compare cutaneous lesion reflectance images, obtained using broadband polarized light, to standard white light images and pathologic analysis of biopsied tissue.
· To acquire near real-time reflectance confocal images of the peripheral edges of lesions (tumor margins) in surgical specimens from cutaneous lesions.
    · To compare the tumor margins defined by fluorescence and reflectance imaging and confocal microscopy to those defined clinically and by histopathology.

    · To analyze images to determine which specific wavelength combinations yield the most diagnostically useful data to discriminate normal from dysplastic and carcinomatous skin area.
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    Study Status Information
    Study Activation / Registration Date:
    IRB Review and Approval Date:09/20/2006
    Study Type:Other
    Recruitment Status:Open
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

    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 resction of skin lesions.

    3) Persons under the age of 18.

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    Links
    Registration Number: NCT00432471
    Study Information on Clinical Trials Registry (clinicaltrials.gov)

    Other Links:
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    Results


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