Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions

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Brief Title

Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions

Official Title

Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions

Brief Summary

      To obtain data to evaluate whether multispectral digital imaging can assist clinicians to
      screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with
      monochromatic light to excite fluorescence, and polarized white light to generate
      reflectance, exposing abnormalities for real time, clinical diagnosis.

      Primary Objectives:

        1. To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400
           nm, and 450 nm excitation, to standard white light images and pathologic analysis of
           biopsied tissue.

        2. To compare reflectance images of oral mucosa lesion, obtained using broadband polarized
           light, to standard white light images and pathologic analysis of biopsied tissue.

        3. To develop algorithms to discriminate between normal and abnormal tissue

        4. To analyze images to determine which type of optical information (or combination
           thereof) yields the most diagnostically useful data
    

Detailed Description

      All tissue and cells are made of tiny particles that give off small amounts of light. This
      light is called fluorescence. Scientists have learned that cancerous cells and normal cells
      give off different amounts and different types of fluorescence. Scientists need to better
      understand whether fluorescence from the oral cavity (mouth) can be used to tell which cells
      are abnormal. This information can help doctors detect pre-cancers.

      In order to better understand fluorescence, researchers at the Optical Spectroscopy and
      Imaging Lab, Department of Bioengineering, Rice University have developed an instrument that
      can collect and analyze fluorescence without surgically removing any tissue or touching the
      tissue. This instrument takes pictures of oral cavity fluorescence through a microscope. The
      instrument also takes regular live pictures. Scientists hope to study the pictures to better
      understand the differences in fluorescence from normal and abnormal cells. The instrument is
      a standard medical microscope similar to ones used by doctors in their offices to examine
      people's ears. Researchers have attached a special light source to the microscope that
      provides different colors of light. In addition, the microscope has a digital camera attached
      to it so that the researchers can record what they see with the different light colors.

      In this study, a clinician will use the instrument to take pictures of suspicious and normal
      oral cavity lesions. A small sample of the oral lesion (2-4 mm each, the size of a small
      eraser) will be removed or biopsied from the areas that are imaged. A portion of both the
      suspicious and normal areas will be taken to pathology for evaluation. The biopsy from the
      normal appearing area is a biopsy that is additional to those you will receive as part of
      your standard of care. Each participant will have 2-4 biopsies performed, depending upon how
      many areas the examiner feels may be suspicious. Most people who take part in this study will
      be having surgery to remove lesions in the oral cavity anyway, so the biopsies will be
      performed at the time of surgery. For those participants who are not scheduled to have
      surgery, the biopsies will be performed under local anesthesia in the clinic.

      All data will be numerically coded to ensure your confidentiality.

      In addition to the pictures taken and the biopsy, a brief interview will be performed by the
      clinical research staff to discuss possible past local therapies and your personal history of
      tobacco and alcohol use. The interview should take about 10 minutes to complete.

      You will not be told of any of the experimental findings. Information confirming the
      diagnosis will be made available to your treating physician. After this visit and tissue
      collection, your participation in this study will be complete.

      This is an investigational study. A total of 45 patients will take part in this study. All
      will be enrolled at M. D. Anderson.
    


Study Type

Observational


Primary Outcome

Evaluate new imaging technology, MDM (Multispectral Digital Microscope), as a tool for early diagnosis of oral neoplasia


Condition

Oral Cancer

Intervention

Interview

Study Arms / Comparison Groups

 1
Description:  Patients with lesions of the oral cavity mucosa.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

45

Start Date

July 2005

Completion Date

March 2008

Primary Completion Date

March 2008

Eligibility Criteria

        Inclusion Criteria:

          1. Subjects with lesions of the oral cavity mucosa or suspicious for malignancy or
             premalignancy.

          2. Subjects with the ability and willingness to sign an informed consent and
             authorization.

          3. Subjects who develop new lesions or alterations in long-standing lesions are eligible,
             but not required, for re-examination with informed consent.

        Exclusion Criteria:

          1. Persons who are medically unfit to undergo superficial punch biopsies of oral mucosa.

          2. Persons under the age of 18.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ann M. Gillenwater, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00502580

Organization ID

2004-0684


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Ann M. Gillenwater, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2012