Adhesive Capsulitis, Articular Cartilage Injury, Glenohumeral Ligament, Labral Tear, Long Head Biceps Tendon Tear, Rotator Cuff Tear, Rotator Cuff Tendinosis, Rotator Cuff Tendonitis
Conditions
Keywords
contrast agent, contrast enhancement in magnetic resonance imaging, Magnetic Resonance Arthrography
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.
Interventions
DRUGNEMO-103 Injection
15mL(at least 12mL), solution for Intravenous injection, single dose
Sponsors
Inventera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed