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临床试验/NCT06294418
NCT06294418已完成不适用

Non-invasive In-vivo Characterisation of Postoperative Low Grade Gliomas Using Field Cycling Imaging (FCI)

NHS Grampian1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
NHS Grampian
入组人数
9
试验地点
1
主要终点
Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles

研究概览

简要总结

The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.

The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan.

详细描述

Standard clinical magnetic resonance imaging (MRI) is the mainstay of diagnosis in brain lesions. It is a powerful imaging technique for the non-invasive investigation of the brain and has been an incredibly successful technology since its commercialisation in the 1980s largely due to its excellent spatial resolution and ability to distinguish multiple tissues in multiple planes. When exogenous contrast agents are used, MRI can demonstrate the breakdown of the blood-brain barrier and provide additional physiological information.

However, standard MRI has limitations in determining the subtypes of tumours, which originate from different cells and therefore contain differing types of proteins. The aim of this project is to establish if there is a difference in the relaxometry (i.e., loss of MRI signal over time) characteristics of different brain lesions using Field Cycling Imaging (FCI), which is a new technology being developed at the University of Aberdeen.

FCI combines the use of a moderately high magnetic field with the ability to probe low magnetic fields so that one can preserve image resolution while also exploiting the high contrast present at low magnetic fields. This provides quantitative data on the molecular dynamics in the tissues, completely non-invasively.

For this study, the research team will use FCI to try to establish if there is a difference in the relaxometry characteristics of different low-grade gliomas. Ten patients with postoperative low grade glioma will be included. Each participant will be asked to undergo one FCI scan only. FCI images will be acquired on dedicated equipment, specifically built for the purpose of imaging human volunteers and patients. Participants will carry on receiving their routine clinical care before and after their scan.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

入选标准

  • Patients with post operative low-grade glioma.
  • Capacity to give informed consent.
  • Capacity to co-operate with the scanning procedures and duration.
  • Age 16 and above.
  • Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner.
  • Participants who meet the safety criteria for undergoing an MRI scan.
  • Participants must be mobile enough to be positioned onto the FCI scanner couch.

排除标准

  • MRI-incompatible conditions, as detected in the MRI safety screening form.
  • Restrictions to mobility that would prevent the correct positioning in the scanner by trained research radiographer (e.g., severe kyphosis).
  • Participants who are unable to give fully informed consent.
  • Women who are pregnant.
  • Participants who are unable to understand or communicate in English.
  • Patients who suffer from claustrophobia.

研究组 & 干预措施

Low grade glioma

Experimental

Patients with postoperative low grade glioma will undergo one FCI scan.

干预措施: Field Cycling Imaging (FCI) (Device)

结局指标

主要结局

Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles

时间窗: At baseline

Validation of FCI T1 dispersion profiles as a non-invasive technology to differentiate sub-types of low grade glioma.

次要结局

未报告次要终点

研究者

发起方
NHS Grampian
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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