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 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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Fibrosis
• Intervention / Treatment: Drug: Elucirem (Gadopiclenol)

Detailed Description

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).

Based on the investigators previous experience with 0.2 mmol/kg Dotarem, the optimal post-contrast T1 for LGE was when the remote myocardium (i.e. area without scar) had T1 of around 400ms at 12 mins post-contrast. The investigators hypothesize that with 0.05 mmol/kg Elucirem, post T1 will recover to 400 ms faster than 12 minutes after injection. It will likely be between 6 to 10 minutes post-contrast. A serial of T1 mapping will provide the information for timing. However, if myocardial T1 were not reduced short enough or recovers to 400 ms in less than 5 minutes post-contrast with 0.05 mmol/kg Elucirem, that is a sign of inadequate dose. Same evaluation will be performed for 0.075 mmol/kg Elucirem. The investigators hypothesize that if 0.05 mmol/kg falls short, 0.075 mmol/kg should be adequate. Since a single dose (0.1 mmol/kg) of Dotarem is proved to be adequate for LGE in many literatures, less Elucirem should be used to demonstrate its benefit.

Study Procedure: It is a non-randomized cohort study. Participants with precious double dose Dotarem CMR will be recruited. The study has two phases. Phase I is to evaluate the optimal dose, 0.05 mmol/kg (N=5) or 0.075 mmol/kg (N=5) by assessing a serial of the myocardial T1 mapping in normal volunteers. T1 mapping will be acquired every 2.5 minutes after injection to 25 minutes post-contrast. Based on the results of Phase I, the optimal dose will be used in the Phase II scar assessment in patients with a scar from a previous double-dose Dotarem study.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joao Lima, Professor; Phone Number: 4106141284; Email: jlima@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD.
      • Contact: Aysa Ostovaneh; Phone Number: 410-458-0198; Email: aostova2@jh.edu
    • Baltimore, Maryland, United States, 21205
      • Not yet recruiting
      • Johns Hopkins School of Medicine
      • Contact: Michelle Hughes-Lukoski; Email: mhughe17@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.05 mmol/kg Elucirem; a group that receives 0.05 mmol/kg Elucirem	Drug: 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.
Experimental: 0.075 mmol/kg Elucirem; A group that receives 0.075 mmol/kg Elucirem	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of half dose of Elucirem to double dose Dotarem	Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.	1-2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-contrast T1 values	Post-contrast T1 values will be measured.	1-2 years
late gadolinium enhancement (LGE),	late gadolinium enhancement (LGE) will be measured.	1-2 years
Extracellular volume fraction (ECV)	Extracellular volume fraction (ECV) will be measured.	1-2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Guerbet
• Investigators: Principal Investigator: Joao Lima, Professor, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; gadopiclenol
• Other Study ID Numbers: IRB00396901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in Gadolinium Contrast. Data shared will not contain any personal health information (PHI). A statement of work and data use agreement are pre-requisites for data sharing.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication. Data will be made accessible up to 24 months with extensions considered as needed.
• IPD Sharing Access Criteria: Access provided upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No