Abnormalities, Radiation-InducedNCT01692600
Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients
An observational study of Abnormalities, Radiation-Induced, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abnormalities, Radiation-Induced
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
Note that time frame for this study is 1 day, since subjects are only imaged once with no follow-up assessments.
Imaging healthy volunteers
The imaging session of the volunteers takes between 30 to 60 minutes. The imaging procedure of these healthy volunteers is very similar to that explained for the patients; however, all the acquired OCT images of this group would be of healthy oral tissue.
Note that time frame for this study is 1 day, since the volunteers are only imaged once with no follow-up assessments.
**Important note: The aim of this study is to compare the images from patients with those of healthy volunteers and show that there are specific changes in the structural and vascular features of the patients (due to radiation toxicity) when compared to the volunteers. So, the comparison is done between the two cohorts of the study.
Data analysis
For the healthy volunteers, the gathered OCT data will be processed to form structural, Doppler and speckle variance images of healthy oral tissue to serve as a reference. The same procedure will be performed on late oral radiation toxicity patients to reconstruct structural, Doppler and speckle variance images of the site of oral complications. Then, the images of healthy volunteers and patients will be compared in terms of the layer thickness, the back-reflection properties of each layer, and the size and profile of blood flow of the microvasculature. In order to compare these two sets of images quantitatively, certain metrics will be defined based on the images of the healthy volunteers. All these quantitative comparisons of healthy oral tissue and tissue with radiation complication will be used to form an OCT atlas of oral radiation toxicity. Moreover, white-light images of the regions of OCT study will be taken in order to serve as a reference for the superficial complications caused by radiation.
- 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
- Medical subject headings
- Abnormalities, Radiation-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: At the imaging time point [comparison between cohorts]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abnormalities, Radiation-InducedStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex I Vitkin, PhD, Principal investigator, University of Toronto/UHNToronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692600
- Sponsor's protocol ID
- 12-0095-CE
- Status last verified
- Mar 2021
- First submitted
- 30 Aug 2012
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22567578Davoudi 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.
PubMed 23843086Davoudi 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01692600
- Acronym / sponsor ID
- 12-0095-CE
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Note that time frame for this study is 1 day, since subjects are only imaged once with no follow-up assessments.
Imaging healthy volunteers
The imaging session of the volunteers takes between 30 to 60 minutes. The imaging procedure of these healthy volunteers is very similar to that explained for the patients; however, all the acquired OCT images of this group would be of healthy oral tissue.
Note that time frame for this study is 1 day, since the volunteers are only imaged once with no follow-up assessments.
**Important note: The aim of this study is to compare the images from patients with those of healthy volunteers and show that there are specific changes in the structural and vascular features of the patients (due to radiation toxicity) when compared to the volunteers. So, the comparison is done between the two cohorts of the study.
Data analysis
For the healthy volunteers, the gathered OCT data will be processed to form structural, Doppler and speckle variance images of healthy oral tissue to serve as a reference. The same procedure will be performed on late oral radiation toxicity patients to reconstruct structural, Doppler and speckle variance images of the site of oral complications. Then, the images of healthy volunteers and patients will be compared in terms of the layer thickness, the back-reflection properties of each layer, and the size and profile of blood flow of the microvasculature. In order to compare these two sets of images quantitatively, certain metrics will be defined based on the images of the healthy volunteers. All these quantitative comparisons of healthy oral tissue and tissue with radiation complication will be used to form an OCT atlas of oral radiation toxicity. Moreover, white-light images of the regions of OCT study will be taken in order to serve as a reference for the superficial complications caused by radiation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
- Having an oral infection or disease
- Unable to keep the mouth open continuously for 5 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
1 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Background: PubMed 22567578Davoudi 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.
- Results publication: PubMed 23843086Davoudi 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.
- Results publicationDavoudi 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex I Vitkin, PhD principal investigator
University of Toronto/UHNToronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormalities, Radiation-Induced, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692600, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.