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

NCT00502580 | Completed

• 1 other identifier: 2004-0684
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To develop algorithms to discriminate between normal and abnormal tissue
4. 4.To analyze images to determine which type of optical information (or combination thereof) yields the most diagnostically useful data

Conditions

Oral Cancer

Keywords

Oral Cancer; Multispectral Digital Microscope; Multispectral Digital Imaging; Interview; MDM

Outcome Measures

Primary Outcomes (1)

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

  4 Years

Study Arms (1)

1

Patients with lesions of the oral cavity mucosa.

Behavioral: Interview

Interventions

Interview BEHAVIORAL

Interview taking about 10 minutes to complete.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lesions of the oral cavity mucosa.

You may qualify if:

• Subjects with lesions of the oral cavity mucosa or suspicious for malignancy or premalignancy.
• Subjects with the ability and willingness to sign an informed consent and authorization.
• Subjects who develop new lesions or alterations in long-standing lesions are eligible, but not required, for re-examination with informed consent.

You may not qualify if:

• Persons who are medically unfit to undergo superficial punch biopsies of oral mucosa.
• Persons under the age of 18.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

Biospecimen

Retention: SAMPLES WITH DNA

Pictures of suspicious and normal oral cavity lesions along with small sample of oral lesion (2-4 mm each, the size of a small eraser) will be removed or biopsied from the areas imaged.

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ann M. Gillenwater, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 17, 2007
• Study Start: July 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)