- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542373
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Fluorescence &Amp; Reflectance Imaging to Detect Oral Neoplasia
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. 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.
OUTLINE:
Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
- Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease
- Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development
- Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations
Exclusion Criteria:
- Subjects under the age of 18.
- Subjects that are unable or unwilling to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (fluorescent/reflectance imaging, spectroscopy)
Participants' oral cavities are inspected by a clinician using a standard white light headlamp.
Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging.
Standard oral brush biopsies are also performed and examined microscopically.
Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.
|
Undergo oral tissue collection
Other Names:
Mouth tissue examined microscopically for cytologic features
Undergo standard white light headlamp oral examination
Other Names:
Undergo widefield fluorescent and reflectance imaging
Undergo point fluorescent spectroscopy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lesions diagnosed via wide-field fluorescence imaging
Time Frame: Up to 10 years
|
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test.
Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
|
Up to 10 years
|
Lesions diagnosed via point spectroscopy system
Time Frame: Up to 10 years
|
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test.
Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
|
Up to 10 years
|
Lesions diagnosed via non-invasive brush cytology
Time Frame: Up to 10 years
|
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test.
Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
|
Up to 10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann M Gillenwater, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Metabolic Diseases
- Substance-Related Disorders
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Head and Neck Neoplasms
- Stomatognathic Diseases
- Mouth Diseases
- Pathological Conditions, Anatomical
- Anemia
- Skin Diseases, Papulosquamous
- DNA Repair-Deficiency Disorders
- Anemia, Hypoplastic, Congenital
- Anemia, Aplastic
- Congenital Bone Marrow Failure Syndromes
- Bone Marrow Failure Disorders
- Lichenoid Eruptions
- Tobacco Use Disorder
- Fanconi Anemia
- Precancerous Conditions
- Mouth Neoplasms
- Leukoplakia
- Leukoplakia, Oral
- Lichen Planus
Other Study ID Numbers
- 2006-0802 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2015-01903 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA185207 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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