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Trial record 2 of 216 for:    Oral Cancer | Recruiting Studies | NIH

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

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ClinicalTrials.gov Identifier: NCT00542373
Recruitment Status : Recruiting
First Posted : October 11, 2007
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
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 August 23, 2018
Actual Study Start Date  ICMJE August 2007
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
Evaluate Portable Spectroscopy System (PS2), Multispectral Digital Microscope (MDM), + Fast Excitation-Emission Matrix (EEM) Imaging Methods [ Time Frame: 3 years ]
Information obtained from the multispectral images compared with the clinical diagnosis, long-term outcome and the histopathology of any biopsied tissue to evaluate the performance of the optical system and assess any clinical benefit to assist in surveillance.
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 Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
Official Title  ICMJE Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
Brief Summary The goal of this clinical research study is to evaluate fluorescence imaging, widefield fluorescence imaging, point spectroscopy imaging methods, and or/ oral brush cytology that may help doctors monitor patients at an increased risk of developing an oral cancer, including those with pre-cancerous lesions in the mouth.
Detailed Description

The Imaging Methods:

All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence and also reflect light differently. Researchers need to better understand whether fluorescence and reflectance of light from tissues in the mouth can be used to tell whether areas of the mouth are abnormal. This information may help doctors detect pre-cancers and early cancer.

Fluorescence Imaging:

Researchers have developed instruments that shine different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light. This is an imaging system that takes fluorescence pictures through a portable head light.

A second, handheld device, named the Identafi 3000, is similar in size and shape to a standard dental mirror. It uses white, violet, and amber light to highlight abnormal tissue areas. The users, wearing special filter eyeglasses, can evaluate and identify changes in the mouth.

Widefield Fluorescence Imaging:

This is an imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera. Researchers hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells.

Point Spectroscopy System:

This study may also test a technique called fluorescence and reflectance spectroscopy.

Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed. The spectroscopy system has a small probe about the size of a writing pen which is placed gently against the lining of the mouth. The exposed tissues will give off very small amounts of light called fluorescence. This light is not seen by the eye, but is seen by a computer.

Brush Cytology:

This is a method to analyze cells from the lining of the mouth. A brush is used to scrape cells from the mouth. The cells can then be stained and checked under a microscope for pre-cancerous changes.

Study Procedures:

If you agree to take part in this study, a researcher may use fluorescence and/or widefield fluorescence imaging instruments to take pictures of several areas in the mouth. Then, the researcher may gently place point spectroscopy probe on 1-4 normal-looking areas and 1-4 abnormal areas. Different colors of light will be shone on the lining of the mouth through the probe. The light that returns from the tissue is collected through the probe and recorded on the computer.

Then the researcher may press a brush inside your mouth and rotate 5-10 times to collect cells.

Researchers will record whether the doctor thinks the area is normal, abnormal but not suspicious for cancer, pre-cancer, or cancer.

If your doctor thinks it is necessary, as per standard of care, a biopsy of abnormal areas may be performed. If any biopsies are performed, the information learned from the tissue will be compared with the imaging and spectroscopy data.

These procedures should take about 20 minutes.

Length of Study:

You will be on study until you complete the 1-time imaging.

If you agree to the optional procedures, you will be on study for as long as you continue to return to MD Anderson for clinic visits.

This is an investigational study. Up to 300 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Oral Cancer
Intervention  ICMJE
  • Procedure: Portable Spectroscopy System
    Imaging system that shines different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light.
    Other Name: PS2
  • Procedure: Multispectral Digital Microscope
    Imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera.
    Other Name: MDM
  • Procedure: Fast Excitation-Emission Matrix System
    Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed.
    Other Name: Fast EEM4
Study Arms Experimental: PS2 + MDM + Fast EEM4
PS2 imaging system that shines different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light. MDM imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera. Fast EEM4 - Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed.
Interventions:
  • Procedure: Portable Spectroscopy System
  • Procedure: Multispectral Digital Microscope
  • Procedure: Fast Excitation-Emission Matrix System
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: September 17, 2014)
300
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2007)
50
Estimated Study Completion Date August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia).
  2. Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease.
  3. Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development.
  4. Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations

Exclusion Criteria:

  1. Subjects under the age of 18.
  2. Subjects that are unable or unwilling to give informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Ann M. Gillenwater, MD 713-792-6920
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: NCI CTRP )
5R01CA185207 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2018

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