- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704169
Quantitative Endoscopy of H&N
October 18, 2022 updated by: University Health Network, Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Princess Margaret Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spatially registered endoscopy for H&N cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
18 months
|
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
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference between dose distribution using endoscopic gross tumor volume and using standard gross tumor volume
Time Frame: 18 months
|
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
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John Cho, MD, The Princess Margaret Cancer Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
August 12, 2019
Study Completion (Actual)
August 12, 2019
Study Registration Dates
First Submitted
June 27, 2013
First Submitted That Met QC Criteria
March 8, 2016
First Posted (Estimate)
March 9, 2016
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 18, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 13-5914-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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