NCT07057037

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Inventera Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rotator Cuff Tear
• Labral Tear
• Rotator Cuff Tendinosis
• Rotator Cuff Tendonitis
• Articular Cartilage Injury
• Glenohumeral Ligament
• Long Head Biceps Tendon Tear
• Adhesive Capsulitis

Interventions

Type	Name	Description
DRUG	NEMO-103 Injection	15mL(at least 12mL), solution for Intravenous injection, single dose

Timeline

• Start date: 2025-09-23
• Primary completion: 2026-04-14
• Completion: 2026-08-01
• First posted: 2025-07-09
• Last updated: 2026-04-16

Locations

8 sites across 1 country: South Korea