Pathological Validation of Functional Imaging in Head and Neck Squamous Cell Carcinoma. A Prospective, Non-commercial and Mono-centric Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Correlation of functional imaging with tumor hypoxia.
研究概览
简要总结
Chemo-radiotherapy (CRT) is currently the cornerstone in the management of locoregional advanced head and neck cancer (HNC). Optimization of the quality of RT is therefore an important issue, if the investigators want to improve the therapeutic index in HNC. This could be achieved by a more accurate definition of the tumor volume and by identification of radioresistant volumes within the tumor. Recent literature puts in this regard the incorporation of functional imaging (FI) in the RT treatment planning forward as a promising tool.
FI modalities provide an outstanding contrast between tumor and surrounding tissues. This is in contrast to anatomical imaging. Using anatomical imaging in RT treatment planning, sufficient margins need to be placed around the tumor volume in order to compensate for geometric uncertainties. Consequently many surrounding functional structures receive high doses of irradiation, resulting in side effects. It is expected that, using FI in RT treatment planning will make these margins smaller or even unnecessary, which will result in less irradiation of the surrounding tissues. So far only one study has reported a comparison between tumor volume on anatomical (CT and MRI) and FI (PET-CT) modalities with pathological tumor volume. This study showed indeed that the tumor volumes delineated on PET-CT correlated more to tumor volumes defined by pathology and were significantly smaller.
Furthermore, FI provides us with a deeper insight in the tumor's underlying biological activity and microstructure. These techniques can thus help to identify radioresistant subvolumes which might benefit from treatment intensification.
A validation of these FI modalities with pathology is necessary to investigate their true power in tumor delineation and in the identification of radioresistant subvolumes.
详细描述
- BACKGROUND AND SETTING
1.1. INTRODUCTION
Concurrent (chemo-) radiotherapy (CRT) is the current standard of care for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The proximity of important functional structures with the tumour makes treatment however highly complex. Treatment related toxicity can be severe with xerostomia and dysphagia gravely complicating the patient's quality of life. The use of altered fractionation schedules and/or concurrent chemotherapy has resulted in substantial gains in loco-regional control, leading to significant improvements in overall survival. Although the prognosis of patients treated with RT for locally advanced HNSCC is continually improving, there are still a high number of locoregional failures.
Using highly conformal radiotherapy the investigators can increase the therapeutic index by giving higher doses to the more radio-resistant parts of the tumour while maintaining or even reducing dose to the surrounding tissues. Functional imaging can help us to define these radio-resistant subvolumes and help us to delineate the gross tumour volume (GTV) better in the future. Positron emission tomography (PET), Diffusion weighted magnetic resonance imaging (DWI) and Dynamic contrast enhanced MRI (DCE-MRI) can give us further insight in the tumour's underlaying biological and microstructural characteristics. However, at the moment the investigators are not sure how to interpret the different imaging parameters obtained from these functional imaging modalities. Therefore, the investigators want to correlate the imaging parameters with the pathological characteristics of the tumour. On the other hand the investigators want to correlate the GTV defined on the functional imaging modalities with the pathological GTV, and see if these modalities can help us to delineate the GTV more accurately in the future.
1.2. IMAGING MODALITIES
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Histologically confirmed squamous cell carcinoma of the larynx (preferably tumours located within the bone structures of the larynx)
- •Decision of primary surgery with curative intent made by the multidisciplinary group of head and neck tumours at Leuven University Hospital
- •Karnofsky performance status ≥70%
- •Age ≥ 18 years old
- •Gender: Male - Female
- •Informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •Prior irradiation to the head and neck region
- •Medical contraindications for any of the planned investigations
- •Distant metastases
- •Pregnant or lactating women
- •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
- •Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
结局指标
主要结局
Correlation of functional imaging with tumor hypoxia.
时间窗: 2 years after start of the study.
The correlation of DWI, DCE-MRI and FDG-PET with the spatial distribution of hypoxia in patients with head and neck cancer.
次要结局
未报告次要终点
研究者
Dr. Sandra Nuyts
Full Professor, Clinical staff member
Universitaire Ziekenhuizen KU Leuven