Oral Margin Spectroscopy Detection Using Optical Spectroscopy
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00439205
First received: February 21, 2007
Last updated: March 5, 2013
Last verified: March 2013
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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.
Objectives:
The overall objective of this exploratory study is to evaluate the ability of optical spectroscopy to assist in margin detection for tumor resection in the oral cavity. This may provide a non-invasive method to help surgeons delineate the precise areas involved in cancerous or pre-cancerous changes at the time of surgery, which should directly impact the quality of patient care. The specific objectives of this study are to:
- Evaluate the peripheral extent of oral neoplastic lesions using a non-invasive multispectral imaging device and standard white light imaging.
- Evaluate peripheral mucosal tumor margins using a non-invasive spectroscopic point probe device.
- Compare the margins of dysplasia and carcinoma identified by multispectral imaging and spectroscopic data to those defined clinically and by histopathology.
| 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 2015 (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:
- Patients with a lesion or history of a lesion of the oral mucosa.
- Subjects with the ability and willingness to sign an informed consent and authorization.
Exclusion Criteria:
- Persons who are medically unfit to undergo surgery.
- Persons under the age of 18.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439205
Contacts
| Contact: Ann M. Gillenwater, MD | 713-792-8841 |
Locations
| United States, Texas | |
| UT 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 |
| Study First Received: | February 21, 2007 |
| Last Updated: | March 5, 2013 |
| 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 June 17, 2013