High-relaxivity Elucirem contrast for cardiac MRI to detect myocardial scar
Official title: High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
Run by Johns Hopkins University · NCT05954559 · Data updated 2026-11-12
This test will see if a half dose of Elucirem (gadopiclenol) can detect heart muscle scar as well as a double dose of Dotarem in adults who previously had cardiac MRI.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT05954559 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥21 years) from the investigators' prior double-dose Dotarem CMR cohort with eGFR ≥60, weight <120 kg, and ability to tolerate MRI who agree to participate.
✕Probably not a fit
Patients with eGFR <60, incompatible implanted devices or metal fragments, pregnancy, prior severe gadolinium allergy, claustrophobia, or unstable cardiogenic conditions are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Johns Hopkins will enroll adults from a prior double-dose Dotarem CMR cohort to compare reduced doses of Elucirem (0.05 and 0.075 mmol/kg) with historical double-dose Dotarem (0.2 mmol/kg) using T1 mapping and late gadolinium enhancement (LGE). A Phase I dose-evaluation will include about ten participants without scars to time serial post-contrast T1 recovery, followed by non-randomized cohort imaging at the selected dose. The main imaging goal is whether remote myocardium T1 reaches around 400 ms within an acceptable post-contrast window to allow reliable scar visualization, and if 0.05 mmol/kg is inadequate, 0.075 mmol/kg will be tested. Eligible participants must be adults (≥21 years), weigh under 120 kg, have eGFR ≥60 mL/min/1.73 m², and be able to undergo MRI without contraindications.
Why it matters
Potential benefit: If successful, clinicians could use a much lower gadolinium dose for cardiac MRI, reducing patient exposure while maintaining scar detection quality.
How similar studies have gone: Elucirem (gadopiclenol) is FDA-approved for other MRI indications and its higher relaxivity suggests potential, but its use for reduced-dose cardiac scar imaging is largely untested while single-dose Dotarem has been shown adequate in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD.
Baltimore, Maryland, United States Recruiting -
Johns Hopkins School of Medicine
Baltimore, Maryland, United States Not yet recruiting
Study contacts
- Principal investigator: Joao Lima, Professor — Md
- Study coordinator: Joao Lima, Professor
- Email: jlima@jhmi.edu
- Phone: 4106141284
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.