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临床试验/NCT06043791
NCT06043791撤回不适用

Applicability of 3T Shoulder MRI in Detection of Labral Pathology

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年9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
撤回
入组人数
78
试验地点
2
主要终点
Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA

研究概览

简要总结

The purpose of this observational study is to compare image quality between 3 Tesla magnet (3T) non-contrast MRI to the current standard of MR arthrogram (1.5T magnet) in detecting shoulder labral and cartilage pathology.

An orthopedic surgeon on the research team will screen for patients with high probability of labral and/or cartilaginous pathology and the need for advanced imaging. The orthopedic surgeon's inclusion of patients will be based on a thorough clinical exam and obtained history. Patients included in the study will be imaged using both protocols - the current standard of MR arthrogram with a 1.5T magnet and non-contrast imaging with a 3T magnet. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.

详细描述

The specific aim of this investigation is to determine the accuracy and reliability of 3T MRI in the detection of shoulder labral and cartilage pathology as compared to the current standard of MR arthrography with a 1.5T magnet scanner.

Patients who present to a Henry Ford orthopedic clinic associated with a surgeon participating in this study and are indicated for labral surgery will be assessed for eligibility. Patients will be interviewed, and their medical chart reviewed to determine whether they meet inclusion and exclusion criteria. Sections of the medical chart that will be reviewed include history of present illness, medical and surgical history, and the physical exam. Patients who meet criteria for this study will be consented by the surgeon or other key study personnel. A password-protected spreadsheet stored on Henry Ford OneDrive will be used to track patients enrolled in the study and make record of patients who do not meet inclusion criteria.

Patients between 14-65 years of age being seen in orthopedic clinic with shoulder pathology likely requiring surgical intervention will be screened into the study. Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indicated for likely labral surgery
  • Chronic, degenerative labral and/or cartilage pathology
  • Ability to read and understand English
  • Age ≥ 18 years
  • Age ≤ 65 years

排除标准

  • Patient does not complete both the MR arthrogram and 3T non-contrast MRI
  • Unexpected trauma in between the MR arthrogram and 3T non-contrast MRI
  • Age < 18 years
  • Age > 65 years

研究组 & 干预措施

Treatment

Experimental

Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol

干预措施: 1.5 Tesla magnet MR arthrography (Radiation)

Treatment

Experimental

Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol

干预措施: 3 Tesla magnet non-contrast MRI (Radiation)

结局指标

主要结局

Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA

时间窗: 1 week

Consistent diagnosis of labral tear in both imaging modalities done by fellowship-trained radiologists

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Courtney Scher

Orthopedic Surgeon

Henry Ford Health System

研究点 (2)

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