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临床试验/NCT01382290
NCT01382290撤回不适用

Magnetic Resonance Imaging of the Spine

Children's Healthcare of Atlanta2 个研究点 分布在 1 个国家开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2

研究概览

简要总结

Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method for detecting acute injury to the brain and is used on all children undergoing an MRI brain scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study other areas of the body, such as the spinal cord, has been recognised as having great clinical potential. However, two main problems have hindered the clinical application of the technique; firstly, the extreme motion sensitivity of the technique meant that respiratory motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to the bones in the spinal column complicates the application of the techniques developed for the brain to the spine. Recently, several techniques have been developed which address these problems and these are now available on the MRI scanners used at Children's Healthcare of Atlanta.

We now wish to evaluate how well these techniques work on children in a routine clinical setting. For this reason we wish to add a single scan of the spine to the imaging protocol of children receiving a routine scan of the brain or spine. This will permit us to evaluate the image quality in both normal and abnormal spines. We plan on enrolling 60 patients with normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast will be required and the additional imaging time for the diffusion studies will be less than 10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the study.

详细描述

Background and significance

Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method for detecting acute ischaemic injury in the brain and is being increasingly applied to the study of brain structure and organisation (1,2). The technique provides information on the motion of water molecules and uses no ionising radiation. The possibility of using DW MRI to probe neuronal microstructures in highly ordered neuronal systems, such as the spinal cord, has been recognised as having great clinical potential. However, the combination of susceptibility artefacts from the surrounding bony structures, motion of the cerebrospinal fluid (CSF), carotid and vertebral artery pulsations and respiratory motion have hampered clinical studies. Recently, several techniques have been developed to address these problems (3,4) and two of these methods will shortly be available for use at the Scottish Rite campus of CHOA.

We propose to apply DW imaging of the spine to the following groups of patients :

  1. Patients with tethered cords.
  2. Patients with Chiari I malformations.
  3. Normal children undergoing a MRI of the spine.

All of the studies would be performed on children who have already been referred for a MRI and the diffusion sequences would be performed after the requested MRI exam is complete. No additional sedation and/or contrast would be required. Informed consent would be requested from the parents for all of these studies. The additional imaging time required for the diffusion studies would be less than 10 minutes. We plan on enrolling 60 patients with normal spines and 30 patients with abnormal spines in this study.

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

入排标准

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

入选标准

  • Patients with tethered cords.
  • Patients with Chiari I malformations.
  • Normal children undergoing a MRI of the spine.

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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