Clinical Research Directory

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

Sponsor: Inventera Inc.

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.

Official title: Multi-center, Single Arm, Unenhanced MRI-controlled Phase III Study for Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases Requiring MR Arthrography

Key Details

Conditions

Interventions

Locations (8)