NCT02976883已完成2 期
A Phase II, Single Centre Exploratory Study of [18F]HX4 PET/CT Imaging to Detect Hypoxia in Patients With Head and Neck and Lung Cancer, Receiving Radiotherapy With Curative Intent
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
研究概览
简要总结
The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy treatment.
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
- •Patients with:
- •biopsy proven non-small cell carcinoma of the lung >2.5 cm in size with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent or
- •squamous cell carcinoma of the upper aerodigestive tract with a primary tumour or nodal mass >
- •5 cm in size, with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent.
- •Participant must be willing and able to give informed consent for participation in the study.
- •Patients must be 18 years old or above.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Have normal renal function, defined by creatinine clearance of >60 mL/min.
- •Able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination.
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and hospital consultant, if appropriate, to be notified of participation in the study
- •Exclusion criteria
- •Patients who are scheduled for surgery prior to radiotherapy will not be included.
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- •Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines (GFR <60 mL/min per 1.73 m3 for 3 months or more).
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •Participants who have been involved in another research study involving an investigational product in the past 12 weeks.
- •Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the Investigators could compromise the data.
- •Previous cancer diagnosis.
排除标准
- 未提供
研究组 & 干预措施
[18F]HX4 diagnostic PET/CT scan
Experimental
[18F]HX4 (370 MBq) will be administered by a single intravenous injection, after which patients will be required to wait for ≤4.0 h and undergo a PET/CT scan.
干预措施: [18F]HX4 diagnostic PET/CT scan (Other)
结局指标
主要结局
The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
时间窗: 2 years
次要结局
- Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images(5 years)
- Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.(5 years)
研究者
研究点 (2)
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