Diffusion-weighted MRI at 3T Using an Endovaginal Coil: Evaluating the Prognostic Value of the Apparent Diffusion Coefficient Distribution in Stage 1 Cervical Tumours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- To obtain histogram metrics(centiles, skew, kurtosis, entropy) for cervical cancer and compare them between histologically poor prognosis and good prognosis groups.
研究概览
简要总结
This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI at 3T can be used to differentiate different histological characteristics within whole tumours and so determine if the technique could be of prognostic value.
The study hypothesis is that this technique will be able to differentiate tumours with histological features known to be associated with poor prognosis (tumour type, grade and lymphovascular space invasion).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients with presumed early stage cervical cancer being considered for curative surgery
排除标准
- •Ferromagnetic metal implants
- •claustrophobia (MRI incompatibility)
结局指标
主要结局
To obtain histogram metrics(centiles, skew, kurtosis, entropy) for cervical cancer and compare them between histologically poor prognosis and good prognosis groups.
时间窗: 1-2 months post imaging
Pixel by pixel analysis of ADC from tumour regions of interest will be used to derive histograms and the 10th, 25th, 50th, 75th and 90th centile values and histogram skew, kurtosis and entropy values for each tumour will be recorded. The number of regions will vary with tumour volume in each patient, given the mean size of lesions in patients studied in a pilot set, it is envisaged that we will analyse 1-5 regions of interest in each tumour. The data will be analysed separately by 2 observers who will be blinded to the histopathological characteristics and assuming good inter-observer agreement, an average of their results will be used for data analysis. The difference in mean centile ADC values of the distribution and the skewness, kurtosis and entropy values between squamous vs. adenocarcinoma, well/moderately differentiated vs. poorly differentiated tumour regions and the absence vs. the presence of lymphovascular space invasion in that region will be determined.
次要结局
- Establish ADC values associated with poor prognosis tumours(Duration of study, 2-3 years)
研究者
Nandita deSouza
Professor of Translational Imaging
Institute of Cancer Research, United Kingdom