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Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients

This study is currently recruiting participants.
Verified September 2012 by University Health Network, Toronto
Sponsor:
Collaborator:
Dr. Alex Vitkin-Ontario Cancer Institute
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01692600
First received: August 30, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

Radiation therapy of the head and neck cancer patients causes late oral radiation complications such as xerostomia (dry mouth) or mucosal atrophy. Currently, methods such as hyperbaric oxygen are used to treat these complications; however, there are no quantifiable means of assessing the outcome of these methods. At present, subjective methods such as superficial examination of the oral cavity are used, yet complications are known to mostly start in the subsurface layers. In this feasibility study, we apply an imaging technique called optical coherence tomography (OCT) as a means of providing objective and quantifiable images of the subsurface micro-structural and micro-vascular changes of oral tissue. Depth-resolved, micrometer-resolution OCT images provide information on changes associated with late radiation complications.


Condition
Abnormalities, Radiation-Induced

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Comparison between the oral layer structure of radiation toxicity patients and healthy volunteers as shown in the OCT structural images [ Time Frame: at the imaging time point [comparison between cohorts] ] [ Designated as safety issue: No ]
    Structural OCT images of the oral tissue of the late radiation toxicity patients will be taken and will be processed to highlight any differences between them and the healthy human oral tissue. An example of the expected differences (in the patients compared to healthy volunteers) is total loss of basal layer and thus loss of differentiation between epithelium and lamina propria in the patients.


Secondary Outcome Measures:
  • Comparison between vascular structure and blood flow properties in the vascular OCT images of radiation toxicity patients and healthy volunteers as shown in the OCT vascular images [ Time Frame: At the imaging time point [comparison between cohorts] ] [ Designated as safety issue: No ]
    Doppler OCT and speckle variance OCT images will be taken to reveal information on the blood flow and vascular structure, respectively. These images will be processed and information about the blood flow, size of the vasculature, and vessel density of the radiation toxicity patients will be extracted and the average values will be compared to those of healthy human volunteer cases


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy volunteers
Late oral radiation toxicity patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The study population are selected from the patients who have received radiation as a treatment for head and neck cancer and have developed late radiation toxicity in their oral tissue. This population is selected among the patients who can open their mouth more than 2 centimeters (so that the imaging probe can be inserted into their oral cavity)

Criteria

for the patients:

  1. Must have undergone radiation therapy of the head and neck site
  2. Must have developed some form of late oral radiation toxicity
  3. Attending the radiation late effects clinic at PMH

For the healthy volunteers:

1- Generally healthy

Exclusion criteria for the patients:

  1. Unable to keep the mouth open for more than 3 minutes
  2. Unable to open the mouth more than 2cm (to admit the OCT probe)
  3. Having loose teeth

for the healthy volunteers:

  1. Having an oral infection or disease
  2. Unable to keep the mouth open continuously for 5 minutes
  3. Unable to open the mouth more than 2cm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692600

Contacts
Contact: BAHAR DAVOUDI, MASc. 416 946 4501 ext 5615 bahar.davoudi@utoronto.ca

Locations
Canada, Ontario
Princess Margaret Hospital/UHNTorotno Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Bahar Davoudi, MASc.     416 946 4501 ext 5615     bahar.davoudi@utoronto.ca    
Sponsors and Collaborators
University Health Network, Toronto
Dr. Alex Vitkin-Ontario Cancer Institute
Investigators
Principal Investigator: Alex I Vitkin, PhD University of Toronto/UHNToronto
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01692600     History of Changes
Other Study ID Numbers: 12-0095-CE
Study First Received: August 30, 2012
Last Updated: September 24, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Late oral radiation toxicity
head and neck cancer patients
optical coherence tomography
subsurface imaging
 mirometer-resolution imaging
vascular imaging
Doppler optical coherence tomography
speckle variance optical coherence tomography

Additional relevant MeSH terms:
Congenital Abnormalities
Abnormalities, Radiation-Induced
Head and Neck Neoplasms
Radiation Injuries
 Wounds and Injuries
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013