Myocardial FibrosisPhase 4NCT05954559
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
A Phase 4 study testing Elucirem (Gadopiclenol) in people with Myocardial Fibrosis, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Fibrosis
- What is being tested?
- Elucirem (Gadopiclenol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants from previous double-dose Doatrem CMR study who are willing to participate and sign the consent will be enrolled in this study. Participants must be ≥21 years old, less than 120kg, not claustrophobic, and eGFR be 60 and more.
Who cannot join
- Participants under 21 years old will be excluded. Contraindications or limitations to contrast-enhanced MRI such as self-report of kidney disease, including kidney transplant or kidney surgery, eGFR less than 60, Metal fragments in eyes, brain, or spinal cord, Internal electrical devices such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator, pregnancy, allergic reaction to gadolinium in the past, claustrophobia, and cardiogenic shock or unstable condition that cannot tolerate the MRI scan will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD.
Baltimore, Maryland, 21202
Aysa Ostovaneh, 410-458-0198, aostova2@jh.edu
- Not yet recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Michelle Hughes-Lukoski, mhughe17@jh.edu
About this study
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.
The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.
Read the detailed description
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
Based on the investigators previous experience with 0.2 mmol/kg Dotarem, the optimal post-contrast T1 for LGE was when the remote myocardium (i.e. area without scar) had T1 of around 400ms at 12 mins post-contrast. The investigators hypothesize that with 0.05 mmol/kg Elucirem, post T1 will recover to 400 ms faster than 12 minutes after injection. It will likely be between 6 to 10 minutes post-contrast. A serial of T1 mapping will provide the information for timing. However, if myocardial T1 were not reduced short enough or recovers to 400 ms in less than 5 minutes post-contrast with 0.05 mmol/kg Elucirem, that is a sign of inadequate dose. Same evaluation will be performed for 0.075 mmol/kg Elucirem. The investigators hypothesize that if 0.05 mmol/kg falls short, 0.075 mmol/kg should be adequate. Since a single dose (0.1 mmol/kg) of Dotarem is proved to be adequate for LGE in many literatures, less Elucirem should be used to demonstrate its benefit.
Study Procedure: It is a non-randomized cohort study. Participants with precious double dose Dotarem CMR will be recruited. The study has two phases. Phase I is to evaluate the optimal dose, 0.05 mmol/kg (N=5) or 0.075 mmol/kg (N=5) by assessing a serial of the myocardial T1 mapping in normal volunteers. T1 mapping will be acquired every 2.5 minutes after injection to 25 minutes post-contrast. Based on the results of Phase I, the optimal dose will be used in the Phase II scar assessment in patients with a scar from a previous double-dose Dotarem study.
- Conditions
- Myocardial Fibrosis
- Being tested
- Elucirem (Gadopiclenol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elucirem (Gadopiclenol)Drug
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| 0.05 mmol/kg Elucirem | Experimental | a group that receives 0.05 mmol/kg Elucirem Receives: Drug: Elucirem (Gadopiclenol) |
| 0.075 mmol/kg Elucirem | Experimental | A group that receives 0.075 mmol/kg Elucirem Receives: Drug: Elucirem (Gadopiclenol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of half dose of Elucirem to double dose Dotarem
Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
Measured: 1-2 years
Secondary outcomes (3)
Post-contrast T1 values
Post-contrast T1 values will be measured.
Measured: 1-2 years
late gadolinium enhancement (LGE),
late gadolinium enhancement (LGE) will be measured.
Measured: 1-2 years
Extracellular volume fraction (ECV)
Extracellular volume fraction (ECV) will be measured.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FibrosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized cohort study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
- Investigators
- Joao Lima, Professor, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954559
- Sponsor's protocol ID
- IRB00396901
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in Gadolinium Contrast. Data shared will not contain any personal health information (PHI). A statement of work and data use agreement are pre-requisites for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
- ClinicalTrials.gov ID
- NCT05954559
- Acronym / sponsor ID
- IRB00396901
- Conditions
- Myocardial Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jul 2023 (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.
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.
The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.
Detailed description
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
Based on the investigators previous experience with 0.2 mmol/kg Dotarem, the optimal post-contrast T1 for LGE was when the remote myocardium (i.e. area without scar) had T1 of around 400ms at 12 mins post-contrast. The investigators hypothesize that with 0.05 mmol/kg Elucirem, post T1 will recover to 400 ms faster than 12 minutes after injection. It will likely be between 6 to 10 minutes post-contrast. A serial of T1 mapping will provide the information for timing. However, if myocardial T1 were not reduced short enough or recovers to 400 ms in less than 5 minutes post-contrast with 0.05 mmol/kg Elucirem, that is a sign of inadequate dose. Same evaluation will be performed for 0.075 mmol/kg Elucirem. The investigators hypothesize that if 0.05 mmol/kg falls short, 0.075 mmol/kg should be adequate. Since a single dose (0.1 mmol/kg) of Dotarem is proved to be adequate for LGE in many literatures, less Elucirem should be used to demonstrate its benefit.
Study Procedure: It is a non-randomized cohort study. Participants with precious double dose Dotarem CMR will be recruited. The study has two phases. Phase I is to evaluate the optimal dose, 0.05 mmol/kg (N=5) or 0.075 mmol/kg (N=5) by assessing a serial of the myocardial T1 mapping in normal volunteers. T1 mapping will be acquired every 2.5 minutes after injection to 25 minutes post-contrast. Based on the results of Phase I, the optimal dose will be used in the Phase II scar assessment in patients with a scar from a previous double-dose Dotarem study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized cohort study
| Arm | Type | Receives |
|---|---|---|
| 0.05 mmol/kg Elucirem | Experimental | Drug: Elucirem (Gadopiclenol)a group that receives 0.05 mmol/kg Elucirem |
| 0.075 mmol/kg Elucirem | Experimental | Drug: Elucirem (Gadopiclenol)A group that receives 0.075 mmol/kg Elucirem |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants from previous double-dose Doatrem CMR study who are willing to participate and sign the consent will be enrolled in this study. Participants must be ≥21 years old, less than 120kg, not claustrophobic, and eGFR be 60 and more.
Key exclusion criteria (1 listed)
- Participants under 21 years old will be excluded. Contraindications or limitations to contrast-enhanced MRI such as self-report of kidney disease, including kidney transplant or kidney surgery, eGFR less than 60, Metal fragments in eyes, brain, or spinal cord, Internal electrical devices such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator, pregnancy, allergic reaction to gadolinium in the past, claustrophobia, and cardiogenic shock or unstable condition that cannot tolerate the MRI scan will be excluded.
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 |
|---|---|---|
| Elucirem (Gadopiclenol)Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. | Drug | 0.05 mmol/kg Elucirem, 0.075 mmol/kg Elucirem |
Primary outcome
Non-inferiority of half dose of Elucirem to double dose Dotarem
Time frame: 1-2 years
Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
3 secondary outcomes
Post-contrast T1 values
Time frame: 1-2 years
late gadolinium enhancement (LGE),
Time frame: 1-2 years
Extracellular volume fraction (ECV)
Time frame: 1-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in Gadolinium Contrast. Data shared will not contain any personal health information (PHI). A statement of work and data use agreement are pre-requisites for data sharing.
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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.
Joao Lima, Professor principal investigator
MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elucirem (Gadopiclenol) in people with Myocardial Fibrosis, run by Johns Hopkins University at 2 sites in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joao Lima, Professor (4106141284, jlima@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of half dose of Elucirem to double dose Dotarem (time frame: 1-2 years). 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 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.