With its high relaxivity, Elucirem™ is designed to deliver high-quality CNS and body lesion visualization giving you the diagnostic confidence* you would expect but at half the conventional gadolinium dose1-4
* Diagnostic confidence was a secondary criterion.
Elucirem™ has up to 3 times the relaxivity of approved GBCAs1
† Gadopiclenol relaxivity measured at 1.41 T in human serum.
This graph is not intended to compare the efficacy or safety of the products shown here. For complete product information, refer to each product’s Summary of Product Characteristics.
Higher relaxivity = increased contrast enhancement
The Phase III PICTURE Trial3
Brain and Central Nervous System (CNS) MRI
The PICTURE trial demonstrated that Elucirem™ at a dose of 0.05 mmol/kg was non-inferior to Gadovist® at a dose of 0.1 mmol/kg in terms of CNS lesion visualization3
The sensitivity and specificity of Elucirem™ for detection of specific pathology are not known.
In the PICTURE trial, a majority of radiologists expressed an overall diagnostic preference for CNS images acquired with Elucirem™ (gadopiclenol) compared to an approved GBCA3‡
‡ Elucirem™ (gadopiclenol) MRI vs. MRI with gadobutrol, extended full analysis set (n=256). Overall diagnostic preference was assessed in a global matched-pairs fashion by 3 blinded readers.
The Phase III PROMISE Trial4
Body MRI
The PROMISE trial demonstrated that Elucirem™ at a dose of 0.05 mmol/kg was non-inferior to Gadovist® at a dose of 0.1 mmol/kg in terms of body lesion visualization4
Doctors did not express a diagnostic preference in the PROMISE trial.
The sensitivity and specificity of Elucirem™ for detection of specific pathology are not known.
Prospective, multicenter, randomized, double-blind, controlled, crossover design vs Gadovist® (gadobutrol)
Primary outcome measures
• Lesion visualization criteria for ELUCIREM™-enhanced MRI compared with unenhanced MRI
• Lesion visualization criteria for ELUCIREM™ compared with Gadovist®
• For each reader, only matching lesions between paired images of Gadovist® and ELUCIREM™ were considered
Lesion visualization criteria
• Borderline delineation
• Internal morphology
• Degree of contrast enhancement
• 256 patients were randomized: Mean age was 57 years (18-84); 53% were female
• 250 patients received at least one injection
• 242 patients received both contrast agents and completed the trial (study duration/patient: minimum 4 days, maximum 23 days)
Inclusion criteria
• Patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted blood brain barrier (primary and secondary tumors)
• Lesions based on results of a previous imaging procedure performed within 12 months prior to ICF signature
Exclusion criteria
• Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) 30 mL/min/ 1.73 m² assessed within 1 day prior to each contrast agent injection
• Patient presenting extracranial lesions and/or extradural lesions
Prospective, multicenter, randomized, double-blind, controlled, crossover design vs Gadovist® (gadobutrol)
Primary outcome measures
• Lesion visualization criteria for ELUCIREM™-enhanced MRI compared with unenhanced MRI
• Lesion visualization criteria for ELUCIREM™ compared with Gadovist®
• For each reader, only matching lesions between paired images of Gadovist® and ELUCIREM™ were considered
Lesion visualization criteria
• Borderline delineation
• Internal morphology
• Degree of contrast enhancement
• 304 patients were randomized : Mean age was 57 years (21-86); 59% were female
• 300 patients received at least one injection
• 275 patients received both contrast agents and completed the trial (study duration/patient: minimum 4 days, maximum 23 days)
Inclusion criteria
• Presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region§
• Abnormalities identified based on a previous imaging procedure performed within 12 months prior to ICF signature
Exclusion criteria
• Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) 30 mL/min/ 1.73 m² assessed within 1 day prior to each contrast agent administration
§US patients were restricted to the breast in compliance with local approved indications of gadobutrol. Trademarks are the property of their respective owners.
Want to find out more about the high kinetic stability of Elucirem™?
GBCA: Gadolinium-Based Contrast Agent
ICF: Informed Consent Form
MRI: Magnetic Resonance Imaging
References
1. Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol. 2019 Aug;54(8):475-484.
2. Elucirem Summary of Product Characteristics. 2023.
3. Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313.
4. Kuhl C, Csőszi T, Piskorski W, et al. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology. 2023 Jul;308(1):e222612.
Click here for the SmPC. For more information, please refer to your local product information