Clinical trial · Observational
Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormalities, Radiation-Induced | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- healthy volunteers
- description
- Age-matched with the patient group, with no oral pathologies and comorbidities
- label
- Late oral radiation toxicity patients
- description
- Head-and-neck cancer patients who had undergone radiation therapy and developed late radiation side ffects
Primary outcomes (1)
- measure
- Comparison between the oral layer structure of radiation toxicity patients and healthy volunteers as shown in the OCT structural images
- timeFrame
- at the imaging time point [comparison between cohorts]
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDDavoudi 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
- RESULTDavoudi 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
- RESULTDavoudi 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