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临床试验/NCT06487767
NCT06487767尚未招募不适用

The Validity of the Use of Imaging in Cervical Cancer Staging

University of Pretoria1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leon Snyman

Professor

University of Pretoria

研究点 (1)

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