Actively Recruiting
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
Led by Johns Hopkins University · Updated on 2026-04-13
25
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
G
Guerbet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants from previous double-dose Dotarem cardiac MRI study willing to participate and sign consent
- Age 21 years or older
- Weight less than 120 kg
- Not claustrophobic
- Estimated glomerular filtration rate (eGFR) of 60 or higher
You will not qualify if you...
- Under 21 years old
- Kidney disease, kidney transplant, or kidney surgery
- eGFR less than 60
- Presence of metal fragments in eyes, brain, or spinal cord
- Internal electrical devices such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator
- Pregnancy
- Past allergic reaction to gadolinium contrast
- Claustrophobia
- Cardiogenic shock or unstable condition that prevents tolerating MRI scan
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
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, 21202
Actively Recruiting
2
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
Research Team
J
Joao Lima, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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