NCT02651701已完成不适用
Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
研究概览
简要总结
The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy.
- •Patients who sign informed consent.
排除标准
- •Patients who are contraindication for CECT
- •Patients who are contraindication for MRI/CE-MRI
- •patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR
- •Patients who were already diagnosed with an active other cancers.
- •Premenopausal female patients who are pregnant.
- •Patients with fasting serum glucose level (>200mg/dL) on blood glucose meter prior to WB MR-PET.
- •Patients who are physically compromised to undergo WB MR-PET.
结局指标
主要结局
the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
时间窗: 12 months
the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated.
次要结局
- concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up(18 months)
- incidence of recommendation for further workup after examination(12 months)
- concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.(12 months)
研究者
Jeong Hee Yoon
MD
Seoul National University Hospital
研究点 (1)
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