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临床试验/NCT03140306
NCT03140306已完成不适用

Use of Low Dose CT Scanning of the Abdomen and Pelvis Using Model Based Iterative Reconstruction (MBIR) in Patients With Inflammatory Bowel Disease: Prospective Clinical Evaluation of Diagnostic Efficacy, Safety and Patient Outcome.

University College Cork1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study

研究概览

简要总结

This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment of patients with inflammatory bowel disease who need CT to assess for disease complications.

详细描述

The purpose of this study is to clinically validate the sole use of a low-dose computed tomography (CT) protocol to reduce the cumulative radiation dose in patients with inflammatory bowel disease. In an earlier study using the same CT parameters, the efficacy of the low dose technique was confirmed in the setting of a blinded retrospective review comparing the findings of the low dose and the conventional dose scan. The purpose of this study is to determine the reliability of the using low dose scan in a prospective clinical setting

This is to be achieved using Model Based Iterative Reconstruction (MBIR) which has been shown to result in diagnostically acceptable low-dose CT imaging while providing a significant reduction of ionising radiation dose to the patient. The authors aim to apply MBIR to their low dose protocol, and to facilitate diagnostic quality CT scanning of the abdomen and pelvis at an effective dose approximately four times less than what would normally occur with an abdominopelvic CT in patients with suspected active Crohn's disease (CD).

The authors plan to assess the diagnostic efficacy, safety and patient outcome of low dose CT reconstructed with MBIR in CD patients presenting to hospital with suspected acute mural and extramural complications.

Patients with inflammatory bowel disease referred to Cork University Hospital (CUH) will undergo two series of the abdomen and pelvis: a modified low dose protocol designed to impart a radiation exposure of 10-20% that of a routine abdominal and pelvic CT and a conventional dose protocol designed to impart an effective dose of 80-90% that of a routine abdominal and pelvic CT. Using this strategy, the image quality and diagnostic yield of the low dose CT can be compared with that of the conventional dose CT and no patient will incur additional radiation exposure as a result of recruitment into the study.

The low dose scan will be read alone initially by one of two experienced radiologists and the diagnostic report will come from this data set only. This report will be placed on the Picture Archiving and Communication System (PACS) to be used by the referring clinician who will then use the report/low dose scan images for patient management. This methodology is used to ascertain the clinical efficacy in a real world setting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

the reader of the ct is blinded to the clinical presentation

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with inflammatory bowel disease requiring CT to assess for disease complication

排除标准

  • Pregnancy or children

结局指标

主要结局

Low-dose CT scanning of the abdomen and pelvis using Model Based Iterative Reconstruction (MBIR) in patients with inflammatory bowel disease: Clinical verification study

时间窗: 2 years

CT study assessing efficacy of reduced dose CT compared with normal dose CT

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

Owen O'Connor

Senior Lecturer

University College Cork

研究点 (1)

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