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临床试验/NCT06988007
NCT06988007尚未招募不适用

Bone Arches: Performance of Pseudo-scanner Sequences in Segmenting the Extent of the Tumour and in Planning Surgical Resection Using the CT Scan as a Reference

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
122
试验地点
2
主要终点
Evaluation of the absolute error of surgical margins

研究概览

简要总结

The goal of this exploratory interventional study aims to evaluate the performance of "pseudo-scanner" MRI sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

详细描述

The management of bone sarcomas is complex, and imaging plays an important role in both diagnosis and treatment monitoring. MRI is the method of choice to provide accurate information on the extent of the bone tumor and its relationship to adjacent soft tissues. However, an additional CT scan is routinely performed and combined with MRI images (spatial realignment) using software and relying on manual control and/or correction. This is essential during surgical planning to i) ensure resection with properly defined safety margins and ii) allow for accurate bone reconstruction.ing.

This exploratory interventional study aims to evaluate the performance of "pseudo-scanner" MRI sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • diagnosis of bone sarcoma with surgical indication

排除标准

  • Implanted material incompatible with MRI.
  • Severe claustrophobia.
  • Pregnant women

研究组 & 干预措施

Whole body MRI

Other

Whole body MRI (ZTE sequence)

干预措施: Whole body MRI (Device)

结局指标

主要结局

Evaluation of the absolute error of surgical margins

时间窗: through study completion, an average of year

The error values observed in the study by Cartiaux et al. to assess the reduction in absolute error of surgical margins obtained when using a computer-assisted cutting procedure (using 3DSide software installed on a laptop belonging to 3Dside, made available to the doctoral student) compared to freehand cutting are used to size the present study. The objective is to compare the absolute error resulting from a cutting procedure assisted by this 3DSide software based on "pseudo-scanner" imaging with that resulting from the same procedure based on standard scanner imaging.

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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