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Oral Margin Spectroscopy Detection Using Optical Spectroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439205
First Posted: February 23, 2007
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this clinical research study is to evaluate an imaging technology that may help clinicians see how far an area of pre-cancerous or cancerous tissue extends in the mouth.

Condition Intervention
Oral Tumors Device: FastEEM4 System Device: Multispectral Digital Microscope

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Oral Tumor Margin Detection Using Optical Spectroscopy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of using optical imaging and spectroscopy to assist in margin detection for tumor resection in the oral cavity. [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples With DNA
Tissue removal and study biopsies to be done so that researchers can better compare the appearance and diagnosis at these sites to the images that were taken.

Enrollment: 58
Actual Study Start Date: February 7, 2007
Study Completion Date: October 10, 2017
Primary Completion Date: October 10, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MDM + FastEEM4
Multispectral digital microscope (MDM) + FastEEM4 Systems
Device: FastEEM4 System
The FastEEM4 probe is moved toward the edge of the lesion(s) until it measures what appears to be normal mouth tissue.
Device: Multispectral Digital Microscope
The MDM instrument will take pictures of abnormal-appearing and normal-appearing areas in the mouth.
Other Name: MDM

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with precancerous or cancerous oral lesions.
Criteria

Inclusion Criteria:

  1. Patients with a lesion or history of a lesion of the oral mucosa.
  2. Subjects with the ability and willingness to sign an informed consent and authorization.

Exclusion Criteria:

  1. Persons who are medically unfit to undergo surgery.
  2. Persons under the age of 18.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439205


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health (NIH)
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: NCT00439205     History of Changes
Other Study ID Numbers: 2006-0673
1R21DE016485-01 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2007
First Posted: February 23, 2007
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Oral Tumors
Oral Margin Spectroscopy
Oral Spectroscopy
Optical Spectroscopy
Oral neoplastic lesions
FastEEM4 System
Multispectral Digital Microscope
MDM
Nonstandard imaging technology

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases