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Trial record 4 of 4 for:
"Erythroplasia"
Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
This study is currently recruiting participants.
Verified August 2016 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00542373
First received: October 10, 2007
Last updated: August 12, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Oral Cancer | Procedure: Portable Spectroscopy System Procedure: Multispectral Digital Microscope Procedure: Fast Excitation-Emission Matrix System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Fluorescence & Reflectance Imaging to Detect Oral Neoplasia |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Oral Cancer
Lip and Oral Cavity Cancer
Leukoplakia
Erythroplakia
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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 under the age of 18.
- Subjects that are unable or unwilling to give informed consent.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542373
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542373
Contacts
| Contact: Ann M. Gillenwater, MD | 713-792-6920 |
Locations
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Ann M. Gillenwater, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
| Principal Investigator: | Ann M. Gillenwater, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| 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: NCI CTRP ) 5R01CA185207 ( U.S. NIH Grant/Contract ) |
| Study First Received: | October 10, 2007 |
| Last Updated: | August 12, 2016 |
Keywords provided by M.D. Anderson Cancer Center:
|
Erythroplakia Oral Cancer Oral Cavity Mucosa Leukoplakia Fluorescence Imaging Reflectance Imaging |
Multispectral Digital Microscope Portable Spectroscopy System Fast Excitation-Emission Matrix PS2 MDM Fast EEM4 |
Additional relevant MeSH terms:
|
Mouth Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on July 13, 2017