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High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
NCT05954559 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Elucirem (Gadopiclenol)
Study Locations (2)
Maryland
- Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD. — Baltimore
- Johns Hopkins School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2026-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05954559
The ClinicalTrials.gov registry entry for NCT05954559 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myocardial Fibrosis appearing as the primary indexed condition, and to 1 intervention — of which Elucirem (Gadopiclenol) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05954559 reports 2 study locations spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05954559 about?
NCT05954559 is a clinical study titled "High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment". 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 lesion...
What is the current status of trial NCT05954559?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2025-08-01. Estimated completion is 2026-04.
What conditions does trial NCT05954559 study?
This clinical trial studies the following conditions: Myocardial Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05954559?
The interventions under investigation include: Elucirem (Gadopiclenol) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05954559?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05954559 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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