Phase 3 Study of the Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases

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

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.

Inclusion Criteria:

1. Age ≥19 years at the time of informed consent.
2. Suspected or known shoulder joint diseases requiring MRA for diagnosis or evaluation at screening.
3. 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.

Exclusion Criteria:

1. Subjects with contraindications to MRI
2. Subjects expected to be clinically unstable during the study
3. 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.
4. 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.
5. Determined to be ineligible to participate in the study by the investigator due to any other reasons.