MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer
2019年8月16日 更新者:The Leeds Teaching Hospitals NHS Trust
A Pilot Study Investigating the Use of Co-registered 18FDG-PET-CT and MRI for Radiotherapy Planning in Locally Advanced Head and Neck Squamous Cell Carcinoma
Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow.
In order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour.
At present a computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment.
The investigators know that other types of scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are better than CT scans at showing areas involved by the cancer.
However, radiotherapy cannot be directly planned on these types of scans.
The aim of this study is to explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target.
In addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy.
If the radiotherapy planning process can be improved in these ways, the investigators hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment.
The study aims to recruit 16 patients.
All patients within the study will undergo a PETCT and an MRI scan prior to starting treatment as part of the study.
A subgroup of 8 patients will undergo additional imaging at two timepoints during the course of their radiotherapy.
The study is noninterventional and patients' standard treatment will not be affected by their participation in the study.
研究概览
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age ≥18
- WHO Performance status 02
- Histologically proven squamous cell carcinoma of the head and neck region
- Clinical decision made to proceed with a course of radiotherapy of curative intent of 6670Gy in 3335 fractions over six and a half to seven weeks with or without concurrent chemotherapy
- Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
- Able to provide fully informed written consent
- Able to lie flat for 1 hour
- Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.
Exclusion Criteria:
- Hypersensitivity to fluorine-18 FDG
- Hypersensitivity to iodinated contrast media or Gadolinium
- Poorly controlled diabetes
- Acute renal failure or moderate renal impairment (estimated glomerularb filtration rate < 30 mL/min)
- Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
- Claustrophobia precluding MRI imaging
- Uncontrolled pain
- Urinary incontinence
- Female patients must not be pregnant and if of child bearing age using adequate contraception
- Breast feeding
- Serious psychiatric comorbidity
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Routine radiotherapy treatment plus MRI scan and PET-CT scan
|
|
其他:Routine radiotherapy treatment
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Feasibility of utilising MRI images in head and neck radiotherapy planning.
大体时间:40-60 minutes
|
Determine whether MRI images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
|
40-60 minutes
|
Feasibility of utilising PET-CT images in head and neck radiotherapy planning.
大体时间:2 hours
|
Determine whether PET-CT images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
|
2 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年6月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2014年10月14日
首先提交符合 QC 标准的
2014年10月21日
首次发布 (估计)
2014年10月24日
研究记录更新
最后更新发布 (实际的)
2019年8月20日
上次提交的符合 QC 标准的更新
2019年8月16日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
无干预的临床试验
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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