Comparing Head and Neck Endoscopy Procedures

Not Applicable

Completed

• Conditions: Comparing Head And Neck Endoscopy in Healthy Patients
• Interventions: Procedure: Endoscopy

• Registration Number: NCT01181362
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes defined on this volumetric information data set. However, target delineation also depends on disease seen endoscopically which may not be visible on CT. We are developing imaging and tracking technology to improve target delineation in Radiation Therapy (RT) planning for head \& neck cancer using quantitative registration of 2D endoscopic information with CT data. Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery are obtained with the patient in the supine position. The accuracy of the registration will be improved if performed in the same position to prevent mobile soft tissue structures shifting between the upright and supine positions. Since therapy must be performed in the supine position, we intend to check the feasibility of performing endoscopy in the supine treatment position. We will compare and assess patient comfort and endoscopic sightlines during an endoscopy procedure in both the upright and supine positions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Study Start: 2010-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Between 18-70 years of age.
• Willing to give informed consent.

Read More

Exclusion Criteria

• Allergy to topical anesthetic nasal spray (lidocaine).
• Patients who currently have or have had head and neck cancer.
• Currently pregnant or lactating; or serious co-morbid illness (e.g., cardiovascular, pulmonary).
• Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
• Concurrent illness, which prevents the subject from undergoing endoscopy.
• Disorders of the nasal cavity e.g deviated septum

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopy	Endoscopy	-

Primary Outcome Measures

Name	Time	Method
To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions.	4 months

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada