Multi-center, Single Arm, Unenhanced MRI-controlled Phase III Study for Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases Requiring MR Arthrography
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
- 试验地点
- 9
- 主要终点
- Qualitative Image Quality Metrics (Distension, Contrast, Sharpness) to Be Evaluated by Independent Central Readers
研究概览
简要总结
The goal of this Phase 3 clinical trial is to evaluate whether MR arthrography enhanced with NEMO-103 injection (NEMO-103 Inj.) provides superior diagnostic imaging quality compared to unenhanced MRI in patients with known or suspected shoulder joint disorders, such as rotator cuff tendon tears, labral tears, and articular cartilage injuries.
⦁ The primary objective is to determine whether NEMO-103 Inj.-enhanced MR arthrography offers improved imaging quality in terms of joint distension, contrast resolution, and image sharpness compared to standard unenhanced MRI.
Participation Details:
- Each participant will undergo two MRI scans: one unenhanced and one enhanced with NEMO-103 Inj.
- NEMO-103 Inj. will be administered once, during the second study visit.
- Participants will attend a total of three site visits.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years at the time of informed consent.
- •Suspected or known shoulder joint diseases requiring MRA for diagnosis or evaluation at screening.
- •Voluntarily decided to participate in the study and provided written consent after receiving a sufficient explanation about this study and after fully understanding the information.
排除标准
- •Subjects with contraindications to MRI
- •Subjects expected to be clinically unstable during the study
- •Subjects who have received or used another IP or investigational device within 4 weeks or ≥5 half-lives, whichever is longer, prior to informed consent.
- •Pregnant or breast-feeding women, or women of childbearing potential and men who do not agree to use appropriate methods of contraception during the study.
- •Determined to be ineligible to participate in the study by the investigator due to any other reasons.
研究组 & 干预措施
NEMO-103 Injection
干预措施: NEMO-103 Injection (Drug)
结局指标
主要结局
Qualitative Image Quality Metrics (Distension, Contrast, Sharpness) to Be Evaluated by Independent Central Readers
时间窗: 1day procedure
The qualitative image quality metrics (distension, contrast, and sharpness) will be assessed on a 3-point scale (good, fair, poor) for both unenhanced MRI and NEMO-103 Inj.-enhanced MR arthrography. These metrics will evaluate the degree of joint distension, the sharpness of joint margins, and the contrast between joint fluid and surrounding structures.
次要结局
未报告次要终点