Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Cervix Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Visualisation of tumor hypoxia with [18F] HX4 PET imaging
研究概览
简要总结
The aim of this study is:
- to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in cervix cancer,
- to correlate the [18F]HX4 PET images with blood and tissue markers,
- to investigate the quality and optimal timing of [18F]HX4 PET images,
- to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and
- analyze correlation with responses
详细描述
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In Cervix cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, the investigators expect that [18F]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. In a recent phase 1 clinical study from van Loon et al, PET-imaging with [18F]HX4 was feasible without any toxicity. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cervix carcinoma (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma)
- •tumor stages FIGO IB - IVA
- •WHO performance status 0 to 2
- •Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
- •No previous surgery to the Cervix
- •No previous radiation to the Cervix
- •The patient is willing and capable to comply with study procedures
- •18 years or older
- •Written informed consent before patient registration
排除标准
- •Recent (< 3 months) myocardial infarction
- •Uncontrolled infectious disease
- •Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
研究组 & 干预措施
[18F] HX4 PET imaging
injection with [18F] HX4 and PET imaging at baseline and after 20 Gy radiotherapy
干预措施: injection with [18F] HX4 and PET imaging (Other)
结局指标
主要结局
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
时间窗: 2 year
Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging
次要结局
- Image quality of [18F] HX4-PET at different time points(2 year)
- Observation of spatial and temporal stability of [18F] HX4 PET images(2 year)
- Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment(2 year)
- Correlations with Complete Remission rates at 3 months restaging evaluation(2 year)
- Kinetic analysis of HX4(2 year)
- Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)(2 year)
- Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes(2 year)
- Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment(2 year)