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

Launched by INVENTERA INC. · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to take detailed pictures of the shoulder joint to help doctors better diagnose problems like tears or injuries in the rotator cuff, cartilage, or other parts of the shoulder. The study is testing whether using a special injection called NEMO-103 during an MRI scan can provide clearer and more detailed images compared to a regular MRI without the injection. This could help doctors see shoulder injuries more clearly and improve diagnosis and treatment.

People who are 19 years or older with known or suspected shoulder joint problems that need imaging are eligible to join the study. Participants will have three visits to the study site and will undergo two MRI scans: one regular MRI and one MRI with the NEMO-103 injection, which is given only once during the second visit. The trial is not yet recruiting, and certain people, such as those who cannot have an MRI or who are pregnant, will not be able to participate. If you have a shoulder condition and are interested, this study could offer a chance to help improve how shoulder injuries are diagnosed in the future.

Gender

ALL

Eligibility criteria

• 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.