Head and Neck CancerPhase 2NCT02704169
Quantitative Endoscopy of H&N
A Phase 2 study testing Spatially registered endoscopy in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The last decade has seen progressive advances in RT delivery, such as intensity modulated radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly precise radiation dose delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Spatially registered endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to 12 Aug 2019
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥ 18 years
- Histologic diagnosis of squamous cell carcinoma
- Primary cancer of the H\&N
- Intention to treat using external beam radiation therapy as part of standard radiotherapy.
- 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
- Contraindications to full dose radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness
- 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: Comparing GTV Delineation With and Without Spatially Registered Endoscopy
The last decade has seen progressive advances in RT delivery, such as intensity modulated radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more selective treatment of the primary tumour and surrounding neck nodes by reducing the dose inflicted on critical organs at risk without compromising tumour dose and. IMRT has been shown to significantly decrease radiation-induced toxicity, and is now considered standard treatment for H\&N tumors. With these advances in delivery technology, the accurate definition of the target is emerging as the weakest link in the radiotherapeutic treatment chain. Accurate target definition is the primary link on which all subsequent treatment planning and delivery depend and is therefore critical for successful RT. Incorrect target definition can result in poorer outcomes through either less tumour control, more normal tissue toxicity, or both. Computed x-ray tomography (CT) is the standard volumetric imaging modality for RT because of its high resolution, accurate definition of anatomy and its intrinsic measure of electron density necessary for accurate dose calculation. However, its ability to distinguish between tumour and normal tissue is limited due to a lack of contrast for structures of similar electron density and image artifacts for objects of high density. This additional noise can result in large inter-observation variability. Disease visible on endoscopy can be contoured and registered to the planning CT, allowing inclusion of superficial disease invisible on the volumetric CT image dataset into the treatment plan.
- Conditions
- Head and Neck Cancer
- Being tested
- Spatially registered endoscopy
- Keywords
- head and neck cancer, H&N cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially registered endoscopyOther
| Study group | Role | What they receive |
|---|---|---|
| Spatially registered endoscopy for H&N cancer | Experimental | Not described Receives: Other: Spatially registered endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std)
Determine if spatially registered endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std) are significantly different in primary H\&N tumors treated with radiation therapy
Measured: 18 months
Difference between inter-observer variation (V) of endoscopic gross tumor volume and of standard gross tumor volume
Determine if the inter-observer variation (V) of spatially registered endoscopic gross tumor volume contours is significantly less than standard gross tumor volume contours in primary H\&N tumors treated with radiation therapy
Measured: 18 months
Secondary outcomes (1)
Difference between dose distribution using endoscopic gross tumor volume and using standard gross tumor volume
Determine if the dose distributions using spatially registered endoscopic GTV contours and standard GTV contours are significantly different in primary H\&N tumors treated with radiation therapy with regard to both normal tissue radiation exposure and tumor coverage
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJul 2013
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- John Cho, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704169
- Sponsor's protocol ID
- UHN REB 13-5914-C
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2013
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Shi RB, Mirza S, Martinez D, Douglas C, Cho J, Irish JC, Jaffray DA, Weersink RA. Cost-function testing methodology for image-based registration of endoscopy to CT images in the head and neck. Phys Med Biol. 2020 Nov 13;65(20). doi: 10.1088/1361-6560/aba8b3.
PubMed 32702685
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing GTV Delineation With and Without Spatially Registered Endoscopy
- ClinicalTrials.gov ID
- NCT02704169
- Acronym / sponsor ID
- UHN REB 13-5914-C
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, H&N cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Jul 2013
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 9 Mar 2016 (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.
The last decade has seen progressive advances in RT delivery, such as intensity modulated radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more selective treatment of the primary tumour and surrounding neck nodes by reducing the dose inflicted on critical organs at risk without compromising tumour dose and. IMRT has been shown to significantly decrease radiation-induced toxicity, and is now considered standard treatment for H\&N tumors. With these advances in delivery technology, the accurate definition of the target is emerging as the weakest link in the radiotherapeutic treatment chain. Accurate target definition is the primary link on which all subsequent treatment planning and delivery depend and is therefore critical for successful RT. Incorrect target definition can result in poorer outcomes through either less tumour control, more normal tissue toxicity, or both. Computed x-ray tomography (CT) is the standard volumetric imaging modality for RT because of its high resolution, accurate definition of anatomy and its intrinsic measure of electron density necessary for accurate dose calculation. However, its ability to distinguish between tumour and normal tissue is limited due to a lack of contrast for structures of similar electron density and image artifacts for objects of high density. This additional noise can result in large inter-observation variability. Disease visible on endoscopy can be contoured and registered to the planning CT, allowing inclusion of superficial disease invisible on the volumetric CT image dataset into the treatment plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spatially registered endoscopy for H&N cancer | Experimental | Other: Spatially registered endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histologic diagnosis of squamous cell carcinoma
- Primary cancer of the H\&N
- Intention to treat using external beam radiation therapy as part of standard radiotherapy.
- Ability to provide written informed consent to participate in the study
Key exclusion criteria (5 listed)
- Prior complete or partial radiation therapy to H\&N
- Prior complete or partial surgery of the tumour
- Contraindications to full dose radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatially registered endoscopy | Other | Spatially registered endoscopy for H&N cancer |
Primary outcome
Difference between endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std)
Time frame: 18 months
Determine if spatially registered endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std) are significantly different in primary H\&N tumors treated with radiation therapy
Difference between inter-observer variation (V) of endoscopic gross tumor volume and of standard gross tumor volume
Time frame: 18 months
Determine if the inter-observer variation (V) of spatially registered endoscopic gross tumor volume contours is significantly less than standard gross tumor volume contours in primary H\&N tumors treated with radiation therapy
1 secondary outcome
Difference between dose distribution using endoscopic gross tumor volume and using standard gross tumor volume
Time frame: 18 months
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 19 Oct 2022.
- Derived from this study: PubMed 32702685Shi RB, Mirza S, Martinez D, Douglas C, Cho J, Irish JC, Jaffray DA, Weersink RA. Cost-function testing methodology for image-based registration of endoscopy to CT images in the head and neck. Phys Med Biol. 2020 Nov 13;65(20). doi: 10.1088/1361-6560/aba8b3.
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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.
John Cho, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spatially registered endoscopy in people with 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 5 inclusion and 5 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 19 Oct 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference between endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT02704169, which also lists 1 linked publication.
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 19 Oct 2022; AzTrials last refreshed its copy on 5 Nov 2026.