The Validity of the Use of Imaging in Cervical Cancer Staging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer
详细描述
Patients with cervical cancer undergoing surgery will also undergo PET-CT scan, CT scan, trans-abdominal ultrasound of the pelvis and abdomen to assess pelvic and para-aortic lymph node status, MRI and trans-vaginal ultrasound (TVUS) to assess tumour size and parametrial infiltration. As per the current unit protocol, patients will be assessed clinically for operability. The performance of the different imaging modalities will be measured against the histological status of the parametric and lymph nodes and tumour size as measured by the pathologists.
CT, PET-CT, MRI and abdominal ultrasound will be reported as per the usual departmental process. Staff in the radiology department will be blinded for the different imaging modalities performed. TVUS will be performed in the unit by different gynaecological oncologists and fellows and at the time of the investigation will be blinded with regards to clinical findings and the reports of other imaging studies performed.
The sensitivity, specificity, positive and negative predictive values will be calculated for the different imaging modalities.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with cervical cancer Able and willing to provide informed consent
排除标准
- •Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment
结局指标
主要结局
Sensitivity and specificity
时间窗: 2 years
Metrics of imaging
次要结局
未报告次要终点
研究者
Leon Snyman
Professor
University of Pretoria
