Intra-individual randomised comparison of gadobutrol 1.0 M versus gadobenate dimeglumine 0.5 M in patients scheduled for preoperative breast MRI.
OBJECTIVE
To demonstrate non-inferiority of gadobutrol versus gadobenate dimeglumine by intra-individually comparing 0.1 mmol/kg body weight doses for contrast-enhanced breast magnetic resonance imaging (MRI) and prospectively evaluating lesion detection and characterisation in a multicentre trial.


METHODS
Two identical breast MRI examinations were performed in 72 patients with biopsy-proven breast cancer, separated by 1-7 days. Gadobutrol 1.0 M or gadobenate 0.5 M were administered in a randomised order. Lesion detection and characterisation were performed by two independent blinded readers. Lesion tracking, which compared on-site readings and histology from surgery or biopsy, was performed by a third reader. Differences in lesion detection and characterisation were compared between the two contrast agents.


RESULTS
Among 103 lesions, 96 were malignant and 7 were benign. No difference in lesion detection was identified between the contrast agents (82.33 % for gadobutrol, 81.60 % for gadobenate). Assessment of sensitivity in lesion characterisation and Breast Imaging Reporting and Data Systems showed no difference between gadobutrol (92.63 %) and gadobenate (90.53 %). Regarding morphology, there was more non-focal enhancement for gadobutrol than for gadobenate (P = 0.0057).


CONCLUSIONS
Non-inferiority of gadobutrol compared with gadobenate was demonstrated for breast lesion detection and sensitivity in lesion characterisation in breast MRI.
Department of Radiological Sciences, University La Sapienza, Policlinico Umberto I, Rome, Italy. federica.pediconi@uniroma1.it
F
F
Pediconi
R
R
Kubik-Huch
B
B
Chilla
C
C
Schwenke
K
K
Kinkel
D000293:Adolescent; D000328:Adult; D001706:Biopsy; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery; D003287:Contrast Media; D005260:Female; D006801:Humans; D016015:Logistic Models; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008536:Meglumine / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds; D011300:Preoperative Care; D011446:Prospective Studies; D016037:Single-Blind Method
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; C090600:gadobutrol; D008536:Meglumine