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OpenTrials
Completed

NCT Number: NCT02704169

Quantitative Endoscopy of H&N

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spatially registered endoscopy

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

Comparing GTV Delineation With and Without Spatially Registered Endoscopy

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2016
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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