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临床试验/NCT05063019
NCT05063019招募中不适用

Adding Value of Magnetic Resonance Imaging and Magnetic Resonance Enterography for the Pre-operative Assessment of Imaging Peritoneal Cancer Index in Patients With Peritoneal Carcinomatosis

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT

研究概览

简要总结

This is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone.

详细描述

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a new option for patients with peritoneal carcinomatosis and the effectiveness of HIPEC depends on the extend of disease. Currently, pre-operative imaging peritoneal cancer index (PCI) is used to predict the intraoperative tumor extend and completeness of cytoreduction. However, the investigators' previous study and literature review show that imaging PCI usually underestimated intraoperative PCI, resulting in subsequent Open-Close operation. The investigators hypothesize that magnetic resonance imaging (MRI) is a better predictor of the intra-operative PCI than computed tomography (CT), and MR Enterography can better represent tumor deposits in the small intestine. This study aims to test whether the addition of MRI and MR Enterography to CT study improves the prediction performance of the intraoperative PCI and completeness of optimal cytoreduction over CT alone.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with peritoneal carcinomatosis diagnosed by computed tomography
  • •Schedule for operation at our institute

排除标准

  • •Age < 20 years old
  • •Renal function impairment or acute renal failure
  • •Contraindications for magnetic resonance imaging
  • •Primary tumor not origins from colorectal cancer, gastric cancer or ovarian cancer

研究组 & 干预措施

Magnetic resonance imaging and enterography following computed tomography

Experimental

Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.

干预措施: MRI (Diagnostic Test)

结局指标

主要结局

Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT

时间窗: 36 months

The Sugarbaker's Peritoneal Cancer Index scores according to the MR enterography and CT images will be calculated pre-operatively and will be compared to the standard PCI scores obtained during operation. Basically, the scoring system divides the abdominopelvic cavity into 13 separate regions, and each region is scored 0-3 points as follows: 0 point, the absence of tumor; 1 point, tumors \< 0.5 cm in diameter; 2 points, tumors 0.5-5 cm in diameter; 3 points, tumors \> 5 cm in diameter.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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