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

NCT07057037 | Active Not Recruiting Phase 3

• 1 other identifier: IVT-NEM_P3_24
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 8

Brief 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; Glenohumeral Ligament; Long Head Biceps Tendon Tear; Adhesive Capsulitis; Articular Cartilage Injury

Keywords

contrast agent; contrast enhancement in magnetic resonance imaging; Magnetic Resonance Arthrography

Outcome Measures

Primary Outcomes (1)

• Qualitative Image Quality Metrics (Distension, Contrast, Sharpness) to Be Evaluated by Independent Central Readers

  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.

  1day procedure

Study Arms (1)

NEMO-103 Injection

EXPERIMENTAL

Drug: NEMO-103 Injection

Interventions

NEMO-103 Injection DRUG

15mL(at least 12mL), solution for Intravenous injection, single dose

NEMO-103 Injection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inventera Inc.: lead

Study Sites (8)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 0308, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Gangnam Severance Hospital

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

The Catholic University of Korea Seoul ST. Mary's Hospital

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

Asan Medical Center

Seoul, Seoul Teugbyeolsi, 5505, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Bursitis

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: September 23, 2025
• Primary Completion: April 14, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

KR (8)