Recruiting

Elucirem vs. Dotarem

Sponsor:

Johns Hopkins University

Code:

NCT05954559

Conditions

Myocardial Fibrosis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Elucirem (Gadopiclenol)

Study Details

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.

Conditions

Myocardial Fibrosis

Study ID

NCT05954559

Start date

Aug 1, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 0.05 mmol/kg Elucirem

a group that receives 0.05 mmol/kg Elucirem

experimental: 0.075 mmol/kg Elucirem

A group that receives 0.075 mmol/kg Elucirem

Interventions

Elucirem (Gadopiclenol)

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.

Primary outcome measure

  • Non-inferiority of half dose of Elucirem to double dose Dotarem [ Time Frame: 1-2 years ]

Central Contacts and Locations

Central contacts

Joao Lima, Professor

4106141284jlima@jhmi.edu

Locations

Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD.

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Aysa Ostovaneh

410-458-0198aostova2@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-13.