跳至主要内容
临床试验/NCT02704169
NCT02704169已完成2 期

Comparing GTV Delineation With and Without Spatially Registered Endoscopy

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
15
试验地点
1
主要终点
Difference between endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Spatially registered endoscopy for H&N cancer

Experimental

干预措施: Spatially registered endoscopy (Other)

结局指标

主要结局

Difference between endoscopic gross tumor volume contours (GTV-endo) and standard gross tumor volume contours (GTV-std)

时间窗: 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

Difference between inter-observer variation (V) of endoscopic gross tumor volume and of standard gross tumor volume

时间窗: 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

次要结局

  • Difference between dose distribution using endoscopic gross tumor volume and using standard gross tumor volume(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验