Quantitative Endoscopy of H&N

NCT ID: NCT02704169

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-08-12

Brief 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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Spatially registered endoscopy for H&N cancer

Group Type: EXPERIMENTAL

Spatially registered endoscopy

Intervention Type: OTHER

Interventions

Spatially registered endoscopy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Cho, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32702685 (View on PubMed)

Other Identifiers

UHN REB 13-5914-C

Identifier Type: -

Identifier Source: org_study_id