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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
85
15mL(at least 12mL), solution for Intravenous injection, single dose
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGSeoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGYonsei University Health System, Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGKonkuk University Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGGangnam Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGThe Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGKorea University Guro Hospital
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGAsan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
RECRUITINGQualitative 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.
Time frame: 1day procedure
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