High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
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.