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临床试验/NCT06016335
NCT06016335已完成不适用

Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Geometrical accuracy.

研究概览

简要总结

In case of surgical procedures in the head and neck region, MRI in combination with CT of the bone is often the standard modality to visualise bony landmarks for planning, navigation and risk assessment. An important downside of a CT scan is the associated radiation exposure, especially in children. An additional downside is the sedation or general anaesthesia needed for both the MRI and CT scan session in very young children. These downsides could be removed if the CT scan can be substituted by an MRI sequence that can provide the same information as CT. This project aims to determine the feasibility of recreating CT like images of the craniofacial bones from MRI images using machine learning techniques.

研究设计

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

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 from the outpatient ENT (Ear, Nose, Throat)-clinic.
  • Aged 18 years or older.
  • Referred for CT scan of the mastoid, sinonasal complex or face.

排除标准

  • Pregnancy.
  • Contra-indications for MRI or CT.
  • Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination.

结局指标

主要结局

Geometrical accuracy.

时间窗: Within one year after scans have been obtained.

Geometrical accuracy of the bone morphology by determining the mean surface distance in mm between the cortical edges on synthetic CT and on true CT.

Radiodensity accuracy.

时间窗: Within one year after scans have been obtained.

Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast.

Visibility of landmarks.

时间窗: Within one year after scans have been obtained.

Accuracy of the visibility of clinically relevant anatomical landmarks on the synthetic CT images compared to the corresponding true CT images in the adult population, rated by experienced physicians on a 4-point Likert scale (1 = not visible, 4 = very well visible).

次要结局

  • Usefulness.(Within one year after scans have been obtained.)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Merkus

Prof. Dr.

Amsterdam UMC, location VUmc

研究点 (1)

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