Data Sharing With Collaborative Partners to Develop Computer Aided Detection for the Assessment of the Small Bowel Using MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Develop computer software to extract the bowel from the MRI dataset
研究概览
简要总结
Crohn's disease is characterised by an abnormal immunological response within the bowel wall leading to abnormal wall thickening, stricturing (narrowing), fistulation (abnormal connections) to adjacent organs and strictures (narrowing), abnormal motility, and local sepsis (infection). Radiological imaging of the small bowel defines diagnosis, disease extent, biological activity and complications and is vital for timely and efficacious clinical management. Small bowel magnetic resonance imaging (MRI) does not impart ionising radiation and is proving to be a safe, well tolerated and robust method of assessing the small bowel and is widely implemented in the NHS and Europe. MRI evaluates multiple disease related features such as bowel wall thickness and motility which are proving increasing reliable for disease identification, staging, therapeutic guidance and assessment of treatment response.
Currently however radiologists must manually make these measurements which are time consuming and difficult.
There are no computer tools that can quickly and accurate make relevant measurements on MRI to guide patient management. Radiologists at University College Hospital have formed collaborations with groups within University College London (UCL) and around Europe. The investigators have received grant funding to develop computer software to accurately assess the small bowel using MRI over 3 years. To develop this software, it is necessary to use anonymised datasets from patients with and without Crohn's disease undergoing small bowel MRI. Part of this project will require prospective collection of MRI data which has been granted ethical approval as a major amendment to a currently running project (09/H0714/62). The department of Radiology at UCLH has been running a clinical small bowel MRI service since 2005 and have several hundred datasets on its PACS. This current ethics application seeks permission to datashare with the collaborative partners fully anonymised MRI datasets and relevant clinical data from patients previously undergoing small bowel MRI for clinical indications at UCLH.
详细描述
The investigators wish to share with collaborative partners selected fully anonymized MRI datasets and associated relevant clinical data (such as blood tests results, endoscopic findings, histology) acquired as part of routine clinical practice at UCH since 2005.
The collaborative partners are:
- The Centre for Medical Image Computing (CMIC) at UCL
- A European consortium (including UCL as partner and UCLH as subcontractor) which has been awarded an FP7 European grant: University of Delph, Amsterdam medical centre, Eldgenössische Technische Hochschule Zürich, Switzerland, Zuse Institut Berlin, Germany, Biotronics3D Limited UK and Vodera Limited UK.
The investigators wish to share a total of 75 datasets with the FP7 consortium and 300 with CMIC.
Process for the sharing of anonymized datasets acquired as part of clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Had a small bowel MRI at UCLH between 2005 and Sept 2010 as part of routine clinical practice who:
- •Have a clinical standard of reference within 6 weeks of the MRI scan
- •Patients with normal small bowel MRI studies and no clinical evidence of bowel pathology on any additional diagnostic investigations
排除标准
- •Patients <16 or not fulfilling either inclusion criteria
结局指标
主要结局
Develop computer software to extract the bowel from the MRI dataset
时间窗: Through study completion, an average of 10 years
measure parameters which reflect Crohn's disease activity which will be used to create and validate models of those parameters which best reflect disease activity.
次要结局
未报告次要终点