Rotator Cuff TearPhase 3NCT07057037
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
A Phase 3 study testing NEMO-103 Injection in people with Rotator Cuff Tear and Labral Tear, run by Inventera Inc. at 8 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Tear, Labral Tear, Rotator Cuff Tendinosis
- What is being tested?
- NEMO-103 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 23 Sep 2025to 18 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 0308
Yonsei University Health System, Severance Hospital
Seoul, Seoul Teugbyeolsi, 03722
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi, 05030
Gangnam Severance Hospital
Seoul, Seoul Teugbyeolsi, 06273
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, Seoul Teugbyeolsi, 06591
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi, 08308
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 5505
About this study
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
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.
Read more
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.
- Conditions
- Rotator Cuff Tear, Labral Tear, Rotator Cuff Tendinosis, Rotator Cuff Tendonitis, Articular Cartilage Injury, Glenohumeral Ligament
- Being tested
- NEMO-103 Injection
- Keywords
- contrast agent, contrast enhancement in magnetic resonance imaging, Magnetic Resonance Arthrography
- Medical subject headings
- Rotator Cuff Injuries, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMO-103 InjectionDrug
15mL(at least 12mL), solution for Intravenous injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| NEMO-103 Injection | Experimental | Not described Receives: Drug: NEMO-103 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1day procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start23 Sep 2025
- Primary completion14 Apr 2026
- Study completion18 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inventera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057037
- Sponsor's protocol ID
- IVT-NEM_P3_24
- Status last verified
- Nov 2026
- First submitted
- 29 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07057037
- Acronym / sponsor ID
- IVT-NEM_P3_24
- Conditions
- Rotator Cuff Tear, Labral Tear, Rotator Cuff Tendinosis, Rotator Cuff Tendonitis, Articular Cartilage Injury, Glenohumeral Ligament
- Keywords
- contrast agent, contrast enhancement in magnetic resonance imaging, Magnetic Resonance Arthrography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Inventera Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEMO-103 Injection | Experimental | Drug: NEMO-103 Injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEMO-103 Injection15mL(at least 12mL), solution for Intravenous injection, single dose | Drug | NEMO-103 Injection |
Primary outcome
Qualitative Image Quality Metrics (Distension, Contrast, Sharpness) to Be Evaluated by Independent Central Readers
Time frame: 1day procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NEMO-103 Injection in people with Rotator Cuff Tear and Labral Tear, run by Inventera Inc. at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Image Quality Metrics (Distension, Contrast, Sharpness) to Be Evaluated by Independent Central Readers (time frame: 1day procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.