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NCT05954559 · ClinicalTrials.gov registry record · Phase 4
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
A Phase 4 study of Myocardial Fibrosis, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT05954559: Recruiting Phase 4 study of Myocardial Fibrosis, sponsored by Johns Hopkins University.
NCT05954559 is a Phase 4 study of Myocardial Fibrosis that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 25 participants, below the 41-participant average among 4 other Myocardial Fibrosis trials with a reported enrollment target (39% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05954559, a Phase 4 study of Myocardial Fibrosis, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
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 |
What NCT05954559 shows while recruiting
NCT05954559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 41-participant average among 4 other Myocardial Fibrosis trials with a reported enrollment target (39% lower).
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.
NCT05954559 reports a single indexed study location in Maryland.
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.
What interventions are being tested in trial NCT05954559?
The interventions under investigation include: Elucirem (Gadopiclenol) (DRUG).
Who is sponsoring clinical trial NCT05954559?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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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