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

NCT01692600 | Completed

• 1 other identifier: 12-0095-CE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormalities, Radiation-Induced

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison between the oral layer structure of radiation toxicity patients and healthy volunteers as shown in the OCT structural images

  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.

  at the imaging time point [comparison between cohorts]

Secondary Outcomes (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

  At the imaging time point [comparison between cohorts]

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may not qualify if:

• Unable to keep the mouth open for more than 3 minutes
• Unable to open the mouth more than 2cm (to admit the OCT probe)
• Having loose teeth
• for the healthy volunteers:
• Having an oral infection or disease
• Unable to keep the mouth open continuously for 5 minutes
• Unable to open the mouth more than 2cm

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital/UHNTorotno

Toronto, Ontario, M5G 1L7, Canada

Location

Related Publications (3)

• Davoudi B, Lindenmaier A, Standish BA, Allo G, Bizheva K, Vitkin A. Noninvasive in vivo structural and vascular imaging of human oral tissues with spectral domain optical coherence tomography. Biomed Opt Express. 2012 May 1;3(5):826-39. doi: 10.1364/BOE.3.000826. Epub 2012 Apr 2.

  PMID: 22567578 BACKGROUND

• Davoudi B, Morrison M, Bizheva K, Yang VX, Dinniwell R, Levin W, Vitkin IA. Optical coherence tomography platform for microvascular imaging and quantification: initial experience in late oral radiation toxicity patients. J Biomed Opt. 2013 Jul;18(7):76008. doi: 10.1117/1.JBO.18.7.076008.

  PMID: 23843086 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Abnormalities, Radiation-Induced

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Radiation Injuries; Wounds and Injuries

Study Officials

• Alex I Vitkin, PhD

  University of Toronto/UHNToronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 25, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 5, 2021

Record last verified: 2021-03

Locations

CA (1)