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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

Patient imaging

At the imaging session, the patient will be asked to sit on the chair and put her/his chin on the chin-rest and the height of the chair will be adjusted accordingly. Before turning on the light source, the patient will be asked to wear the safety goggles and open her/his mouth while the probe is slowly moved inside the oral cavity. At this point, by looking at the superficial oral tissue, we will find regions in the oral cavity with superficial changes. When such regions are found, OCT images of these regions will be taken. Imaging of each location is expected to take about 3 to 4 minutes (including the time required to find the region of interest, acquisition of structural, Doppler and speckle variance images, and the time between each of these processes). After this, the patient can close her/his mouth and rest for couple of minutes. The same procedure will be performed on another site of complication. The 3-4 minute imaging procedure is repeated 3 to 5 times (depending on the patients' ability to keep the mouth open), after which the patient is dismissed and the sterile probe cover will be disposed. All the acquired data will be stored in a computer which is kept in a locked office. The data will be processed within the week after the imaging session so that structural, Doppler and speckle variance images of the imaged sites of complication can be compared.

During imaging, structural OCT real-time images are shown on the monitor to facilitate the task of finding the region of interest and keeping track of the patient's movements and move the probe accordingly. During the Doppler or speckle variance imaging (approximately 7 seconds each within the 3-4 minutes interval mentioned before), the patient is asked to keep as still as possible, in order to avoid any motion artifact in the OCT images.

Sponsor: PMH Cancer Program

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: August 30, 2012
Date Started: June 2012
Date Completion:
Last Updated: May 7, 2015
Last Verified: May 2015