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Clinical Trials in South Korea / NCT07057037
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science South Korea tracker
Sponsor
Inventera Inc
Phase
Phase 3
Started
2025-09-23
Last updated
2026-04-16

Condition(s) studied

Rotator Cuff TearLabral TearRotator Cuff TendinosisRotator Cuff TendonitisArticular Cartilage InjuryGlenohumeral LigamentLong Head Biceps Tendon TearAdhesive Capsulitis

Investigational drug(s) / intervention(s)

NEMO-103 Injection

NEMO-103 Injection: 15mL(at least 12mL), solution for Intravenous injection, single dose

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (8)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Seoul National University Hospital Seoul Seoul Teugbyeolsi
Yonsei University Health System, Severance Hospital Seoul Seoul Teugbyeolsi
Konkuk University Medical Center Seoul Seoul Teugbyeolsi
Gangnam Severance Hospital Seoul Seoul Teugbyeolsi
The Catholic University of Korea Seoul ST. Mary's Hospital Seoul Seoul Teugbyeolsi
Korea University Guro Hospital Seoul Seoul Teugbyeolsi
Asan Medical Center Seoul Seoul Teugbyeolsi

Other trials for the same condition

Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect? Active, not recruiting
ISB With SSNB & ANB Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07057037 on ClinicalTrials.gov ↗ ← All trials in South Korea