Phase 3 Study of the Efficacy and Safety of MR Arthrograp... | NCT07057037

Studies
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

NCT07057037

Sponsor

Inventera Inc.

Status

Active, not recruiting

Last Update Posted

Apr 16, 2026Actual

Enrollment

85Estimated

Phase

Phase 3

Conditions

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

Interventions

NEMO-103 Injection

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2025Actual

Primary Completion Date

Apr 14, 2026Actual

Completion Date

Aug 2026Estimated

First Submitted Date

Jun 29, 2025

First Submission Date that Met QC Criteria

Jun 29, 2025

First Posted Date

Jul 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

contrast agent
contrast enhancement in magnetic resonance imaging
Magnetic Resonance Arthrography

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NEMO-103 Injection	Experimental		Drug: NEMO-103 Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NEMO-103 Injection	Drug	15mL(at least 12mL), solution for Intravenous injection, single dose	NEMO-103 Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative 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.	1day procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥19 years at the time of informed consent.
Suspected or known shoulder joint diseases requiring MRA for diagnosis or evaluation at screening.
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:

Subjects with contraindications to MRI
Subjects expected to be clinically unstable during the study
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.
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.
Determined to be ineligible to participate in the study by the investigator due to any other reasons.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea
Seoul National University Hospital

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D000070636	Rotator Cuff Injuries
D002062	Bursitis

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries
D007592	Joint Diseases
D009140	Musculoskeletal Diseases