MedTrace Logo

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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-04-16

No results posted yet for this study

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

DRUG

NEMO-103 Injection

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

Sponsors & Collaborators

  • Inventera Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2026-04-14
Completion
2026-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057037 on ClinicalTrials.gov