CLINICAL TRIALS PROFILE FOR ELUCIREM
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All Clinical Trials for ELUCIREM
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05590884 ↗ | Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age | Recruiting | Guerbet | Phase 2 | 2022-09-21 | This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS). |
| NCT05954559 ↗ | High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment | Not yet recruiting | Guerbet | Phase 4 | 2024-09-01 | 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. |
| NCT05954559 ↗ | High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment | Not yet recruiting | Johns Hopkins University | Phase 4 | 2024-09-01 | 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. |
| NCT06057168 ↗ | Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas | Recruiting | Guerbet | Phase 3 | 2023-09-07 | This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas. |
| NCT06226129 ↗ | Gadopiclenol in Contrast Enhanced MRI of the Prostate | SUSPENDED | Guerbet | PHASE4 | 2024-02-14 | The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories. |
| NCT06226129 ↗ | Gadopiclenol in Contrast Enhanced MRI of the Prostate | SUSPENDED | University of Massachusetts, Worcester | PHASE4 | 2024-02-14 | The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories. |
| NCT06846853 ↗ | Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging) | RECRUITING | UConn Health | PHASE4 | 2025-03-01 | This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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