High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment

NCT05954559 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00396901
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-contrast T1 values

  1-2 years

• late gadolinium enhancement (LGE),

  1-2 years

• Extracellular volume fraction (ECV)

  1-2 years

Study Arms (2)

0.05 mmol/kg Elucirem

EXPERIMENTAL

a group that receives 0.05 mmol/kg Elucirem

Drug: Elucirem (Gadopiclenol)

0.075 mmol/kg Elucirem

EXPERIMENTAL

A group that receives 0.075 mmol/kg Elucirem

Drug: Elucirem (Gadopiclenol)

Interventions

Elucirem (Gadopiclenol) DRUG

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.

0.05 mmol/kg Elucirem; 0.075 mmol/kg Elucirem

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Guerbet: collaborator

Study Sites (2)

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

Baltimore, Maryland, 21202, United States

RECRUITING

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

MeSH Terms

Interventions

gadopiclenol

Study Officials

• Joao Lima, Professor

  MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Lima, Professor

CONTACT

4106141284; jlima@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized cohort study

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 20, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• 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.
• Access Criteria: Access provided upon request.

Locations

US (2)