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Study Summary
No. 2006-0802:.......Cancer Prevention; Head And Neck......Ann M. Gillenwater......Head/Neck Surgery
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Study Summary Title
Study Summary
Number:
2006-0802
Study Title:Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
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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:713-792-6920
Contact us about clinical trials
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General Information
Disease Group:Cancer Prevention
Head And Neck
Supported By:NIDCR
Phase of Study:N/AReturn
Visit:
The participants will come to MDACC on a frequent basis determined by the
responsible physician. It is not mandatory any return visits for this study,
but the participants may be eligible to imaging and spectroscopy monitoring on
follow-up visits.
Treatment
Agents:
ImagingHome 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 fluorescence imaging
(including a
new handheld device), widefield fluorescence imaging, and/or point spectroscopy
imaging methods that may help doctors monitor patients at an increased risk of
developing an oral cancer, including those with pre-cancerous lesions in the
mouth.
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Study Objectives / Outcomes
The overall objective of this exploratory study is to evaluate whether widefield multispectral imaging and/or point spectroscopy can assist in follow-up surveillance of patients with high risk for development of oral cancer including those with premalignant lesions in the oral cavity. Digital images obtained using various light wavelength combinations and spectroscopy of specific lesions will be used to examine patients at high risk for oral cancer during routine clinical follow-up examinations. Data will be correlated with standard clinical examination, development of dysplasia and invasive carcinoma, and pathological evaluation of biopsies when available.

The specific aims of the study are:

· To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.

· To assess whether the multispectral images and spectroscopic data provide any added benefit to assist clinicians in surveillance of high risk patients.

This will be an exploratory study designed to obtain images and/or spectroscopic data over time during routine follow-up surveillance of patients at high risk to develop oral cancer. We will investigate based on the following hypotheses:

1. The optical properties of epithelial tissue are altered due to biochemical and architectural changes occurring during malignant conversion. These alterations can be optically detected and used for diagnosis.
2. The human eye can better distinguish alterations in optical properties between non-neoplastic, dysplastic and malignant oral mucosa with the assistance of fluorescence and reflectance imaging.
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Study Status Information
Study Activation / Registration Date:08/27/2007
IRB Review and Approval Date:08/27/2007
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) Subjects with premalignant lesion of the oral cavity mucosa (leukoplakia or erythroplakia).

2) Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease.

3) Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development.

4) Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations

Exclusion Criteria:1) Subjects under the age of 18.

2) Subjects that are unable or unwilling to give informed consent.

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Links
Registration Number: NCT00542373
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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