Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Completion of PET-MRI
研究概览
简要总结
The primary research question to be answered in this project is "Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell?" This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan.
The secondary question is "Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by:
- Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan.
- Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.
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
- •Aged 18 years or over
- •Able to give informed written consent.
- •New diagnosis of biopsy-proven head and neck cancer.
- •WHO performance status ≤
- •MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy.
- •MRI and PET-CT staging scans for diagnosis.
排除标准
- •Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents.
- •Claustrophobia or other contraindications to MRI.
- •Unable to pass through a 55 cm hula hoop.
- •Female patients that are pregnant or breastfeeding.
- •Unable to understand written or spoken English.
- •Patients not undergoing radical intent radiotherapy.
- •Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.
结局指标
主要结局
Completion of PET-MRI
时间窗: 12 months
To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.
次要结局
- Impact of additional PET-MRI on treatment plan(12 months)
- Impact of additional PET-MRI on radiotherapy target volumes(12 months)