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

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ClinicalTrials.gov Identifier: NCT01692600
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
PMH Cancer Program, University Health Network, Toronto

Brief Summary:
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 or disease
Abnormalities, Radiation-Induced

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
healthy volunteers
Age-matched with the patient group, with no oral pathologies and comorbidities
Late oral radiation toxicity patients
Head-and-neck cancer patients who had undergone radiation therapy and developed late radiation side ffects



Primary Outcome Measures :
  1. 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] ]
    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 :
  1. 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] ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 Princess Margaret Cancer Center, Toronto, Canada

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

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): NCT01692600


Locations
Canada, Ontario
Princess Margaret Hospital/UHNTorotno
Toronto, Ontario, Canada, M5G 1L7
Sponsors and Collaborators
PMH Cancer Program
Investigators
Principal Investigator: Alex I Vitkin, PhD University of Toronto/UHNToronto

Publications of Results:
Davoudi B, Bizheva K, Wong A, Dinniwell R, Levin L and Vitkin A. Correlating optical coherence tomography images with dose distribution in late oral radiation toxicity patients. Photonics and Lasers in Medicine 3(4): 311-321, 2014

Other Publications:
Responsible Party: PMH Cancer Program, UHNToronto, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01692600     History of Changes
Other Study ID Numbers: 12-0095-CE
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by PMH Cancer Program, 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:
Head and Neck Neoplasms
Radiation Injuries
Abnormalities, Radiation-Induced
Neoplasms by Site
Neoplasms
Wounds and Injuries
Congenital Abnormalities