High-relaxivity Elucirem contrast for cardiac MRI to detect myocardial scar

High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment

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
• Enrollment: 25 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT05954559 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Baltimore, Maryland and 1 other locations

• 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

Conditions Myocardial Fibrosis