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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05954559
Phase
PHASE4
Status
Recruiting
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Conditions

  • Myocardial Fibrosis

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD.BaltimoreMaryland21202
Aysa Ostovaneh
[email protected]
410-458-0198
Johns Hopkins School of MedicineBaltimoreMaryland21205
Michelle Hughes-Lukoski
[email protected]

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By research site
Johns Hopkins Center for Advanced Imaging and Research Science, located in the Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD.· Baltimore, MDJohns Hopkins School of Medicine· Baltimore, MD

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