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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

Tracking Information
First Submitted Date  ICMJE October 10, 2007
First Posted Date  ICMJE October 11, 2007
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE August 27, 2007
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00542373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Official Title  ICMJE Fluorescence &Amp; Reflectance Imaging to Detect Oral Neoplasia
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Erythroplakia
  • Fanconi Anemia
  • Lichen Planus
  • Oral Cavity and Lip Precancerous Condition
  • Oral Cavity Leukoplakia
  • Oral Neoplasm
  • Premalignant Lesion
  • Tobacco Use Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Procedure: Diagnostic Microscopy
  • Procedure: Diagnostic Procedure
  • Procedure: Fluorescence Imaging
  • Procedure: Fluorescence Spectroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
400
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2007)
50
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ann M. Gillenwater, MD 713-792-6920 agillenw@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00542373
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ann M Gillenwater M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP