Oral Margin Spectroscopy Detection Using Optical Spectroscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00439205
First received: February 21, 2007
Last updated: August 15, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Primary Completion Date: February 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00439205

Contacts
Contact: Ann M. Gillenwater, MD 713-792-8841

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
Investigators
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00439205     History of Changes
Other Study ID Numbers: 2006-0673, 1R21DE016485-01
Study First Received: February 21, 2007
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014