Head and Neck CancerEndoscopicHNNCT03380208
Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation Study
An observational study of Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this clinical research is to compare new methods of identifying the locations of tumours to standard CT imaging. Analysis of the tissue removed during surgery (pathology) will be used to determine which method is more accurate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2017to 30 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck cancer, specifically of the oral cavity
Who may be able to join
- Patients will be eligible for inclusion in this study if they meet all of the following criteria:
- Age ≥ 18 years Histologic diagnosis of oral squamous cell carcinoma Primary cancer of the H\&N Intention to treat using surgery. Ability to provide written informed consent to participate in the study
Who cannot join
- Prior complete or partial radiation therapy to H\&N Prior complete or partial surgery of the tumour Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning Psychiatric or addictive disorders that preclude informed consent or adherence to protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation
The purpose of this clinical research is to compare new methods of identifying the locations of tumours to standard CT imaging. Analysis of the tissue removed during surgery (pathology) will be used to determine which method is more accurate. Accurately identifying the locations of tumours is especially important for radiation therapy, where the radiation needs to cover the entire tumour while minimizing the amount normal tissue that is exposed to radiation. The new method uses optical imaging (endoscopy) that can be mapped to the CT imaging using device tracking technologies. CT imaging is used to create the radiation treatment plans and so tumour locations are normally provided by CT images. The advantage of the new technology that is being tested is that it may be able to locate regions of a tumour that are at the surface of the tissue. These tumours are difficult to see using CT imaging but easy to see using optical imaging. Currently, there is no accurate way of mapping the optical imaging to the CT images used in radiation therapy.
This study will enable the investigators to test the new optical imaging by comparing the tumour that the investigators identify using CT imaging alone against using CT imaging plus the optical imaging technology. The results from this imaging will be compared to pathology findings.
Read the detailed description
a CT image that includes a contrast agent that helps to identify the location of the tumour. Small markers will be placed on the participants head prior to the scan so that the investigators can align this CT image with the tracking technology used during the surgery.
The participant will be moved to the surgical table, where the surgery will proceed as it would for standard of care procedures. The tracking technology and optical imaging will be used to identify where the tumour is located at the tissue surface
- Tumour tissue and extra tissue surrounding the tumour will be removed, as would occur normally in surgery. Some markers may be placed on the tissue where it is cut. These will be helpful in matching the tissue that is removed with its location in the images.
- A second CT image will be taken immediately following the tissue removal. This will be made using an imaging device called a cone beam CT.
- In collaboration with the pathology department, whole mount tissue samples will be assessed to determine the location of tumour tissue. Using the markings on the tissue and images taken of the tissue sample after it has been removed, the location of the tumour in the tissue sample will be compared to the location of the tumour in the CT image and the location of the surface tumour determined by the optical imaging technology.
- The CT images may be analyzed by radiation oncologists, surgeons and physicists.
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
CT image comparison of lesions visible in the oral cavity with pathological findings of the resected specimen.
Relative spatial overlap of mucosal lesions in the oral cavity as detected by endoscopic imaging and gross tumor as detected by CT imaging, with confirmation of lesion pathology and location determined by whole mount pathology of the resected samples. The endoscopic imaging is co-registered to the CT image set using tracking devices embedded inside the endoscopes.
Measured: intraop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Dec 2017
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Irish, Dr., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380208
- Sponsor's protocol ID
- 17-5386
- Acronym
- EndoscopicHN
- Status last verified
- Mar 2024
- First submitted
- 14 Nov 2017
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation
- ClinicalTrials.gov ID
- NCT03380208
- Acronym / sponsor ID
- EndoscopicHN / 17-5386
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Dec 2017 (actual)
- 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.
The purpose of this clinical research is to compare new methods of identifying the locations of tumours to standard CT imaging. Analysis of the tissue removed during surgery (pathology) will be used to determine which method is more accurate. Accurately identifying the locations of tumours is especially important for radiation therapy, where the radiation needs to cover the entire tumour while minimizing the amount normal tissue that is exposed to radiation. The new method uses optical imaging (endoscopy) that can be mapped to the CT imaging using device tracking technologies. CT imaging is used to create the radiation treatment plans and so tumour locations are normally provided by CT images. The advantage of the new technology that is being tested is that it may be able to locate regions of a tumour that are at the surface of the tissue. These tumours are difficult to see using CT imaging but easy to see using optical imaging. Currently, there is no accurate way of mapping the optical imaging to the CT images used in radiation therapy.
This study will enable the investigators to test the new optical imaging by comparing the tumour that the investigators identify using CT imaging alone against using CT imaging plus the optical imaging technology. The results from this imaging will be compared to pathology findings.
Detailed description
a CT image that includes a contrast agent that helps to identify the location of the tumour. Small markers will be placed on the participants head prior to the scan so that the investigators can align this CT image with the tracking technology used during the surgery.
The participant will be moved to the surgical table, where the surgery will proceed as it would for standard of care procedures. The tracking technology and optical imaging will be used to identify where the tumour is located at the tissue surface
- Tumour tissue and extra tissue surrounding the tumour will be removed, as would occur normally in surgery. Some markers may be placed on the tissue where it is cut. These will be helpful in matching the tissue that is removed with its location in the images.
- A second CT image will be taken immediately following the tissue removal. This will be made using an imaging device called a cone beam CT.
- In collaboration with the pathology department, whole mount tissue samples will be assessed to determine the location of tumour tissue. Using the markings on the tissue and images taken of the tissue sample after it has been removed, the location of the tumour in the tissue sample will be compared to the location of the tumour in the CT image and the location of the surface tumour determined by the optical imaging technology.
- The CT images may be analyzed by radiation oncologists, surgeons and physicists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck cancer, specifically of the oral cavity
Key inclusion criteria (2 listed)
- Patients will be eligible for inclusion in this study if they meet all of the following criteria:
- Age ≥ 18 years Histologic diagnosis of oral squamous cell carcinoma Primary cancer of the H\&N Intention to treat using surgery. Ability to provide written informed consent to participate in the study
Key exclusion criteria (1 listed)
- Prior complete or partial radiation therapy to H\&N Prior complete or partial surgery of the tumour Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning Psychiatric or addictive disorders that preclude informed consent or adherence to protocol
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
CT image comparison of lesions visible in the oral cavity with pathological findings of the resected specimen.
Time frame: intraop
Relative spatial overlap of mucosal lesions in the oral cavity as detected by endoscopic imaging and gross tumor as detected by CT imaging, with confirmation of lesion pathology and location determined by whole mount pathology of the resected samples. The endoscopic imaging is co-registered to the CT image set using tracking devices embedded inside the endoscopes.
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 20 Mar 2024.
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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.
Jonathan Irish, Dr. principal investigator
University Health Network, Toronto
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 Head and Neck Cancer, 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 2 inclusion and 1 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 20 Mar 2024. 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?
CT image comparison of lesions visible in the oral cavity with pathological findings of the resected specimen. (time frame: intraop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.