Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 10
- 主要终点
- Diagnostic performance of the techniques under investigation
研究概览
简要总结
The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.
详细描述
Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour and nodal stage as determined on MRI. Unfortunately, the information provided by standard T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response after neo-adjuvant chemoradiotherapy. Additional functional information is required for reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new imaging techniques that have all shown great potential in rectal cancer staging. In order to provide definite evidence there is a need for a multicenter study with a large patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in MRI)
- •Age > 18 years
- •Written informed consent
排除标准
- •Ineligibility to undergo MRI (claustrophobia, pacemaker, non-MR compatible surgical implants, metal fragments in the eye)
- •Pregnancy
- •Locally recurrent rectal cancer
- •A history of severe allergy to contrast agents
- •Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate <30 ml/min/1.73m2
- •Incurable disease due to metastases or co-morbidity
研究组 & 干预措施
Primary staging group I
All patients will be treated according to standard practice of the concerning hospital.
Patients in group I are patients that will be stratified for direct surgery (TME) or a short-course of radiotherapy (5x5 Gy) followed by immediate TME.
Group I will undergo only a staging MRI, including gadofosveset-enhanced MRI.
干预措施: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar] (Drug)
Restaging group II
All patients will be treated according to standard practice of the concerning hospital.
Patients in group II are patients that will be stratified for a long course of chemoradiotherapy.
Group II will undergo a staging MRI, a re-staging MRI and a optional sigmoidoscopy as part of restaging. MRI includes diffusion-weighted imaging and gadofosveset-enhanced MRI.
干预措施: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar] (Drug)
结局指标
主要结局
Diagnostic performance of the techniques under investigation
时间窗: 2 years
Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI.
次要结局
- To determine the inter-observer agreement for the imaging techniques under investigation(2 years)