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

Inventera Inc.

Status and phase: Enrolling; Phase 3

Conditions: Articular Cartilage Injury; Rotator Cuff Tear; Rotator Cuff Tendinosis; Labral Tear; Glenohumeral Ligament; Rotator Cuff Tendonitis; Long Head Biceps Tendon Tear; Adhesive Capsulitis

Treatments: Drug: NEMO-103 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07057037

IVT-NEM_P3_24

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

NEMO-103 Injection

Experimental group

Treatment:

Drug: NEMO-103 Injection