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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer

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ClinicalTrials.gov Identifier: NCT00542373
Recruitment Status : Recruiting
First Posted : October 11, 2007
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

Condition or disease Intervention/treatment Phase
Erythroplakia Fanconi Anemia Lichen Planus Oral Cavity and Lip Precancerous Condition Oral Cavity Leukoplakia Oral Neoplasm Premalignant Lesion Tobacco Use Disorder Other: Cytology Specimen Collection Procedure Procedure: Diagnostic Microscopy Procedure: Diagnostic Procedure Procedure: Fluorescence Imaging Procedure: Fluorescence Spectroscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluorescence &Amp; Reflectance Imaging to Detect Oral Neoplasia
Actual Study Start Date : August 27, 2007
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019


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.
Other: Cytology Specimen Collection Procedure
Undergo oral tissue collection
Other Name: Cytologic Sampling

Procedure: Diagnostic Microscopy
Mouth tissue examined microscopically for cytologic features

Procedure: Diagnostic Procedure
Undergo standard white light headlamp oral examination
Other Names:
  • Diagnostic Method
  • Diagnostic Technique
  • Diagnostic Test

Procedure: Fluorescence Imaging
Undergo widefield fluorescent and reflectance imaging

Procedure: Fluorescence Spectroscopy
Undergo point fluorescent spectroscopy
Other Name: Spectroscopy, Fluorescence




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 that are unable or unwilling to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542373


Contacts
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Contact: Ann M. Gillenwater, MD 713-792-6920 agillenw@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ann M. Gillenwater    713-792-6920      
Principal Investigator: Ann M. Gillenwater         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ann M Gillenwater M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00542373     History of Changes
Other Study ID Numbers: 2006-0802
NCI-2015-01903 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006-0802 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01CA185207 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Precancerous Conditions
Leukoplakia
Mouth Neoplasms
Leukoplakia, Oral
Fanconi Anemia
Lichen Planus
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Anemia
Hematologic Diseases
Bone Marrow Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Neoplasms
Pathological Conditions, Anatomical
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases