An Exploratory Study on Optical Assessment of Oral Mucositis

July 18, 2012 updated by: M.D. Anderson Cancer Center

Objectives:

  1. To assess the tolerability of performing optical coherence tomography and/or optical spectroscopy in patients with acute oral mucositis.
  2. To determine the feasibility of obtaining optical coherence tomography images and/or fluorescence excitation emission matrices from normal and affected sites in patients with acute oral mucositis.
  3. To compare optical data obtained with optical coherence tomography and/or spectroscopy with the clinical appearance and scoring of oral mucositis lesions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Optical coherence tomography (OCT) works similarly to ultrasound but uses infrared light waves rather than sound waves to create high-resolution pictures. This tool has been approved by the Food & Drug Administration (FDA), is used routinely for standard diagnosis of eye conditions, and is now being used to look inside your mouth for tissue changes.

For the OCT procedure, a small probe, about the size of a pencil eraser, will be gently placed against the lining of your mouth and light will be shone through the probe to create pictures of the tissue. The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth. If there are no abnormal-looking areas, researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue, since these are the areas most often affected by the chemotherapy and radiation therapies.

In fluorescence spectroscopy (FS), a small beam of light, shines through a small probe onto the lining of the mouth. A small amount of light will be emitted from the tissue in the form of fluorescence, similar to "glow in the dark" toys . This light is not seen by the eye, but it is detected by the probe and recorded by a computer.

For the FS procedure, a small probe, about the size of a pencil eraser, will be gently placed against the lining of your mouth and light will be shone through the probe. The probe will then collect the fluorescence light signals and they will be recorded on a computer. The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth. If there are no abnormal-looking areas, researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue, since these are the areas most often affected by the chemotherapy and radiation therapies.

If you agree to take part in this study, your mouth will be examined before your treatment begins, and then once a week after that. Every week, you will also be asked how much pain you are having on a scale of 1-10.

Photographs will be taken of the inside of the mouth with a standard camera. You will not be identified in these photographs.

You will be asked to return once a week until you finish all radiation treatments to have all the exams repeated. Most radiation treatments last about 6-8 weeks.

This is an investigational study. About 18 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.

Description

Inclusion Criteria:

  1. Patients greater than 18 years old.
  2. Patients undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
  3. Subject must sign an informed consent indicating awareness of the investigational nature of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OCT + FS + Questionnaire
Optical Coherence Tomography (OCT) + Fluorescence Spectroscopy (FS) and Questionnaire
Procedure: Optical Coherence Tomography
Before radiation treatment and once a week thereafter.
Other Names:
  • OCT
Procedure: Fluorescence Spectroscopy
Before radiation treatment and once a week thereafter.
Other Names:
  • FS
Behavioral: Pain Scale Questionnaire
Administered before the examination, OCT, and FS and immediately afterward.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optical assessment of oral mucositis in patients undergoing radiation or chemoradiation for head and neck cancer treatment
Time Frame: Two sets of oral scans; one at baseline and the second 2 weeks into therapy
Two sets of oral scans; one at baseline and the second 2 weeks into therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (ESTIMATE)

June 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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