NCT05954559 High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
| NCT ID | NCT05954559 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Johns Hopkins University |
| Condition | Myocardial Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 25 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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.
Contact & Investigator
Joao Lima, Professor
PRINCIPAL INVESTIGATOR
MD
Frequently Asked Questions
Who can join the NCT05954559 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Myocardial Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05954559 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05954559 currently recruiting?
Yes, NCT05954559 is actively recruiting participants. Contact the research team at jlima@jhmi.edu for enrollment information.
Where is the NCT05954559 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States.
Who is sponsoring the NCT05954559 clinical trial?
NCT05954559 is sponsored by Johns Hopkins University. The principal investigator is Joao Lima, Professor at MD. The trial plans to enroll 25 participants.