跳至主要内容
临床试验/NCT06383585
NCT06383585进行中(未招募)不适用

Evaluation of 3D DL oZTEo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Mayo Clinic
入组人数
25
试验地点
1
主要终点
The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.

研究概览

简要总结

This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI.

详细描述

This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis.

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
否

入选标准

  • •Adult patients ≥18 years of age
  • •Hand radiographs performed within the past 3-6 months with imaging results available for analysis
  • •Hand radiographs confirm the presence of bony erosions
  • •Scheduled for a hand MRI as part of their routine clinical care at Mayo Clinic Rochester

排除标准

  • •- Less than18 years of age

研究组 & 干预措施

oZTEo MRI pulse sequence

Experimental

All patients will have the FDA approved MRI pulse sequence, oZTEo, added to their already ordered standard of care MRI examination.

干预措施: oZTEo (Device)

结局指标

主要结局

The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.

时间窗: 1 day

The primary outcome

次要结局

  • The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.(1 day)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naveen S. Murthy

Principal Investigator

Mayo Clinic

研究点 (1)

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