Christiane Kuhl1 and Alex Merkulov2
1Department of Diagnostic and Interventional Radiology, Aachen University Hospital, Aachen, Germany, 2University of Connecticut Health Center, Farmington, CT, United States
Synopsis
Keywords: Breast, Breast, gadopiclenol; MRI; breast
Motivation: Gadolinium dose reduction while maintaining MRI diagnostic efficacy is crucial.
Goal(s): Compare gadopiclenol (0.05 mmol/kg) and gadobutrol (0.1 mmol/kg) in breast MRI.
Approach: Post-hoc analysis on 70 patients with breast lesions from the PROMISE phase III study.
Lesion visualization was qualitatively (border delineation, internal morphology, contrast enhancement) and quantitatively (enhancement percentage [E%], lesion-to-background ratio [LBR]) evaluated by three blinded readers. Three additional readers assessed diagnostic preference.
Results: Gadopiclenol was non-inferior to gadobutrol for all qualitative visualization parameters.
E% was higher with gadopiclenol, while LBR was similar between the two GBCAs.
Readers had in most cases no preference between images with the two GBCAs.
Impact: Gadopiclenol at half the gadolinium dose compared
to current GBCAs can be particularly beneficial in patients receiving multiple
lifetime doses, such as high-risk women undergoing breast cancer screening.
Purpose
Gadopiclenol (Elucirem™, Guerbet) is a high
relaxivity macrocyclic gadolinium-based contrast agent (GBCA), recently
approved by the FDA at the dose of 0.05 mmol/kg. Gadopiclenol at 0.05 mmol/kg
has been shown to be non-inferior to gadobutrol at 0.1 mmol/kg in terms of
lesion visualization in contrast-enhanced MRI of different body regions overall.(1)
This post-hoc analysis aimed to evaluate specifically
the efficacy of gadopiclenol in contrast-enhanced MRI of the breast.Materials and Methods
This
is a post-hoc analysis of data from the subgroup of patients with breast
lesions (N= 70) included in the PROMISE phase III study,(1) where 277 patients underwent two
separate MRI examinations of different body regions, one with gadopiclenol
(0.05 mmol/kg) and one with gadobutrol (0.1 mmol/kg), in a cross-over design.
Lesion visualization parameters (border delineation, internal morphology and
contrast enhancement) were assessed by 3 independent blinded readers, through a
qualitative scoring (1 to 4) of up to 3 most representative lesions in each
patient. Percentage of enhancement (E%) and lesion to background ratio (LBR)
were measured. Overall diagnostic preference was assessed in a global
matched-pairs fashion by 3 additional blinded readers.Results
For all readers, and all lesion visualization
parameters, the difference in mean of scores showed the non-inferiority of
gadopiclenol to gadobutrol for breast lesions (lower limit of 95%CI between
-0.21 and -0.05, above the non-inferiority margin [-0.35]).
Regarding quantitative measurements, E% was higher
with gadopiclenol for all 3 readers (p≤0.02), while there were no significant
differences between the two contrast agents for LBR (p≥0.1).
Readers reported in majority no preference between
images with gadopiclenol and those with gadobutrol (77.1%, 80.0%, 97.1% of the
evaluations). Conclusion
Gadopiclenol at 0.05 mmol/kg is non-inferior
to gadobutrol at 0.1 mmol/kg for breast contrast-enhanced MRI. The
reduction in gadolinium dose achieved with gadopiclenol at half the standard
dose of other GBCAs may be particularly important in high-risk women undergoing
multiple contrast-enhanced MRI examinations for breast cancer screening.Acknowledgements
No acknowledgement found.References
1. Kuhl C, Csoszi T, Piskorski W,
Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol
versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology
2023;308(1):e222612.