Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Association with treatment failure
研究概览
简要总结
Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to treatment outcomes.
详细描述
Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The investigators wish to investigate using this methodology to identify hypoxic subvolumes within HNSCC that may have greater resistance to standard radiotherapy treatment and investigate the association of such hypoxic regions with treatment outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-patient Volunteer Inclusion Criteria:
- •Age 18 years and above
- •Signed written informed consent
- •Patient Inclusion Criteria:
- •Histologically proven or strong clinical suspicion of squamous cell carcinoma of the head and neck
- •Suitable for undergoing radical radiotherapy or chemoradiotherapy according to local protocols within the head and neck Cancer MDT
- •Age 18 years and above
- •Adequate physical fitness (WHO performance status 0 to 2)
- •Signed written informed consent
排除标准
- •Non-patient Volunteer Exclusion Criteria:
- •Contraindications to MRI scans as identified following completion of the Nottingham University Hospitals NHS Trust (NUH) standard MR safety screening protocol
- •Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
- •Volunteers who are pregnant as identified through the NUH standard MR safety screening protocol
- •Patient Exclusion Criteria:
- •Poor physical fitness (WHO performance status greater than 2)
- •Contraindications to MRI scans as identified following completion of the NUH standard MR safety screening protocol
- •Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
- •Patients who are pregnant or breast-feeding (due to IV contrast use in the routine clinical scan) as identified through the NUH standard MR safety screening protocol
结局指标
主要结局
Association with treatment failure
时间窗: 2 years
Test predictive value of OE-MRI to identify patients with the highest risk of treatment failure and provide data to allow a power calculation for a larger future trial of the predictive power of OE-MRI for treatment outcomes in head and neck cancer treated with radiotherapy.
Number of patients with areas detected within tumours of the head and neck area that have measurable hypoxia using OE-MRI technique.
时间窗: 2 years
Feasibility of OE-MRI scans to detect hypoxic areas within tumours in patients with head and neck squamous cell carcinomas
次要结局
- Tumour perfusion(2 years)