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

StatusRecruiting
PhasePhase 4
Started2025-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-08
minor
Study Status v14
Primary completion date2026-04→2026-12
Completion date2026-04→2026-12
2025-08-07
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v13
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-12→2026-04
Completion date2026-03→2026-04
Start dateestimated 2025-08-15→confirmed 2025-08-01
Enrollment target10→25
Study sites1→2
2025-06-13
minor
Study Status v12
Start date2025-06-15→2025-08-15
2025-04-08
minor
Study Status v11
Start date2025-04-15→2025-06-15
2025-02-04
minor
Study Status v10
Start date2025-02-15→2025-04-15
Show 9 earlier versions
2024-12-05
minor
Study Status v9
Start date2024-12-15→2025-02-15
2024-11-07
minor
Study Status v8
Start date2024-11-15→2024-12-15
2024-10-03
minor
Study Status v7
Start date2024-10→2024-11-15
2024-09-09
minor
Study Status v6
Start date2024-09→2024-10
2024-05-29
minor
Study Status v5
Start date2024-05→2024-09
2024-04-10
minor
Study Status v4
Start date2024-04→2024-05
2024-01-11
minor
Study Status v3
Start date2024-03→2024-04
2024-01-09
minor
Study Status, Sponsor/Collaborators v2
Start date2024-01→2024-03
Collaborators1 entry, revised
Canon Medical Systems, USAGuerbet
2023-09-07
minor
Study Status v1
Start date2023-09→2024-01
2023-07-13
minor
Original filing
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.
Trial Details
NCT Number NCT05954559
Lead Sponsor Johns Hopkins University
Collaborators: Guerbet
Conditions Myocardial Fibrosis
Enrollment 25 participants
Start Date 2025-08-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-13