Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Node Metastases Using PET-CT, CT-Perfusion and 3T MRI: A Prospective Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of Positron emission tomography, Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging studies will be compared to standard imaging studies and the histopathology of the surgical specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases pretreatment better than standard pretreatment scans and will better determine the degree of response of the primary rectal tumor to preoperative chemoradiation.
详细描述
Patient Recruitment:
30 consecutive patients with histologically-proven, non-mucinous rectal cancer will be recruited and stratified into three separate groups as follows:
- T2 tumors (requiring only surgery)
- Early T3 tumors (requiring preoperative standard course radiation therapy)
- Advanced T3 and T4 tumors (requiring preoperative chemoradiation)
Study Protocol:
The pretreatment imaging studies will be performed with a 3T MRI pelvis,PET-CT and CT-Perfusion of the pelvis. The patient will then receive standard treatment consisting of surgery,radiation therapy or a course of neoadjuvant chemoradiation.For patients with T3 and T4 tumors, repeat imaging using all three modalities outlined above will be performed post-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
- •Rectal cancer, stage T2, T3, T4
排除标准
- •Rectal cancer, stage T1 or metastatic
- •Non-rectal primary cancer invading the rectum
- •Mucinous histology
- •Patient is initially, or becomes a non-surgical candidate during the course of the study
- •Hip prosthesis (affects PET-CT image processing)
- •Allergy to CT contrast or patients with impaired renal function, defined as estimated glomerular filtrate rate (eGFR)< 30 ml/min
- •Prior radiotherapy to the region of the study that would result in overlap of radiation fields
- •Contraindications to MRI
- •Pregnancy
结局指标
主要结局
efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer
时间窗: 3 years
The patient will undergo imaging studies with PET, CT-perfusion and MRI before and after standard preoperative chemoradiation and these imaging studies will be compared with standard imaging and with the final pathology specimen in order to determine the accuracy of these 3 studies in detecting lymph node metastases and response of the primary tumour to treatment
次要结局
未报告次要终点
研究者
Barbara Fisher
Doctor
London Health Sciences Centre