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临床试验/NCT06994702
NCT06994702已完成不适用

Evaluation of the Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment: Feasibility Study

Institut Cancerologie de l'Ouest1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2025年5月19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
入组人数
3
试验地点
1
主要终点
To evaluate quality of a synthetic scanner generated from an MRI performed in the position of cerebral radiotherapy treatment with 2 thermoformed masks

研究概览

简要总结

In radiotherapy, CT scans are the reference imaging tool for treatment planning, as they provide the electron density of the tissues required to calculate the dose. Magnetic Resonance Imaging (MRI) is used as a complement to CT to contour target volumes and organs at risk. While the properties of CT allow us to determine the electron density of tissues, the properties of MRI allow us to determine the proton density of tissues. MRI therefore provides better tissue contrast, but cannot be used directly to calculate the dose. In recent years, MRI-only protocols have been introduced to remove the need for a CT examination and avoid possible MRI-CT registration errors. Dose calculations are then performed on MRI images converted into synthetic CT images (sCT) using software based on artificial intelligence (for the most recent). Various commercial solutions are available for generating these sCTs, and the ICO already has experience of evaluating them.

While MRI scans for diagnostic purposes are performed in the free position, the generation of an sCT for treatment preparation requires the MRI scan to be performed in the radiotherapy position. For cranial lesions, a thermoformed mask fixed to the table is made for each patient. Depending on the type of treatment and its associated degree of precision, different types of mask exist at the ICO: '3-point' for normo-fractionated treatments and 'stereo' for treatments of 1 to 3 fractions. The use of these masks during the MRI examination can interfere with the correct positioning of the antennae and thus lead to a deterioration in the quality of the images obtained (MRI and, by repercussion, sCT).

The aim of this study was to evaluate the impact of the 2 thermoformed masks used at the ICO on the quality of a synthetic scan for 3 healthy volunteers.

研究设计

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

入排标准

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

入选标准

  • •Male > 18 years
  • •Health professional practising at the ICO
  • •Volunteer who has signed the consent form
  • •Volunteer available to carry out the 3 MRI scans

排除标准

  • •Claustrophobia
  • •Foreign metal objects (metal splinters, filings, shotgun pellets, etc.)

研究组 & 干预措施

MRI with thermoformed masks

Experimental

MRI performed in the position of cerebral radiotherapy treatment

干预措施: MRI without mask (Device)

MRI with thermoformed masks

Experimental

MRI performed in the position of cerebral radiotherapy treatment

干预措施: MRI with mask 1 (Device)

MRI with thermoformed masks

Experimental

MRI performed in the position of cerebral radiotherapy treatment

干预措施: MRI with mask 2 (Device)

结局指标

主要结局

To evaluate quality of a synthetic scanner generated from an MRI performed in the position of cerebral radiotherapy treatment with 2 thermoformed masks

时间窗: 1 day

The quality is measured in Hounsfield Units (HU) on each of the structures outlined on the MRI scans and reproduced on the sCT scans.

次要结局

  • Comparison of the quality of MRI images with and without restraint(1 day)
  • Studying the integration of a field map into routine clinical practice(1 day)

研究者

发起方
Institut Cancerologie de l'Ouest
申办方类型
Other
责任方
Sponsor

研究点 (1)

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