Quantitative Endoscopy of H&N

Head and Neck Cancer Clinical Trial

Official title:

Comparing GTV Delineation With and Without Spatially Registered Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704169
• Other study ID #: UHN REB 13-5914-C
• Status: Completed
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: August 12, 2019

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Spatially registered endoscopy

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 months
Primary	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	18 months
Secondary	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	18 months