跳至主要内容
临床试验/NCT07844577
NCT07844577招募中不适用

Multicentre Evaluation of Spinal Bone Pathologies Using Zero Echo Time (ZTE) Pseudo-CT MRI Sequences: a Clinical Implementation Study

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4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
招募中
发起方
入组人数
100
试验地点
1
主要终点
sensitivity and specificity of pseudo-CT MRI

研究概览

简要总结

Innovative sequences known as "pseudo-CT"-such as Ultrashort Echo Time (UTE) and Zero Echo Time (ZTE)-enable good visualization of mineralized bone. These new sequences appear to enhance MRI performance in the detection of fractures, spondylolysis, and other bone abnormalities.

We would like to offer patients referred for a CT scan due to lumbar spine bone pathology the option of undergoing an MRI study, in order to compare the performance of the two techniques.

详细描述

Magnetic resonance imaging (MRI) is the gold-standard modality for examining the bone marrow and soft tissues of the spine, thanks to its excellent contrast resolution. It enables precise visualization of the intervertebral discs, nerve roots, and spinal cord. However, its ability to visualize bone mineral remains limited due to the rapid decay of the T2 signal and the inability of conventional sequences to capture signals from tissues with very short relaxation times. Consequently, assessing bone structures-such as cortical or trabecular bone, osteophytes, or fractures-remains challenging, particularly in cases of complex pathologies.

Innovative sequences known as "pseudo-CT" sequences-such as Ultrashort Echo Time (UTE) and Zero Echo Time (ZTE)-enable the capture of signals from tissues with very short T2 relaxation times and provide good visualization of mineralized bone. These new sequences appear to enhance MRI performance in the detection of fractures, spondylolysis, and other bone abnormalities.

Despite the promising potential of "pseudo-CT" sequences, studies comparing them to conventional CT and MRI sequences remain limited, as do data regarding their overall clinical benefit. Further research is therefore needed to evaluate their diagnostic value, their ability to improve patient management, and their potential to reduce the need for other imaging examinations.

研究设计

研究类型
干预性
分配方式
不适用
干预模型
单组
主要目的
诊断
盲法
开放(无盲法)

入排标准

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

入选标准

  • Adults requiring a CT scan as part of their clinical assessment for lumbar spine imaging who also provide informed consent to participate in the study.
  • Patients presenting with acute or chronic low back pain and requiring a CT scan for diagnostic purposes.

排除标准

  • Contraindications to MRI, such as pacemakers, metal implants, severe claustrophobia, or pregnancy
  • Spinal surgery within the last six months.
  • Patients who cannot or do not wish to provide informed consent.

研究组 & 干预措施

All patients

Experimental

Each patient has a lumbar spine CT scan scheduled as part of their clinical follow-up. We are adding a lumbar spine MRI for the purposes of the study.

干预措施: MRI (Device)

结局指标

主要结局

sensitivity and specificity of pseudo-CT MRI

时间窗: One MRI of 30 min

To evaluate the sensitivity and specificity of pseudo-CT MRI for the detection of bone lesions.

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
其他
责任方
申办方

研究点 (1)

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标识符

NCT 编号
NCT07844577
其他研究编号
2025/05MAI/177

日期

首次提交
(9天前)
首次发布
(前天)
主要完成日期
(6个月后)
研究完成日期
(6个月后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
是否有结果
否

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