Abstract: |
Background: Contrast-enhanced magnetic resonance imaging (CE-MRI) of the breast is highly sensitive for breast cancer detection. Multichannel coils and 3T scanners can increase signal, spatial, and temporal resolution. In addition, the T 1 -reduction effect of a gadolinium-based contrast agent (GBCA) is higher at 3T. Thus, it might be possible to reduce the dose of GBCA at 3T without losing diagnostic information. Purpose: To compare a three-quarter (0.075 mmol/kg) dose of the high-relaxivity GBCA gadobenate dimeglumine, with a 1.5-fold higher than on-label dose (0.15 mmol/kg) of gadoterate meglumine for breast lesion detection and characterization at 3T CE-MRI. Study Type: Prospective, randomized, intraindividual comparative study. Population: Eligible were patients with imaging abnormalities (BI-RADS 0, 4, 5) on conventional imaging. Each patient underwent two examinations, 24–72 hours apart, one with 0.075 mmol/kg gadobenate and the other with 0.15 mmol/kg gadoterate administered in a randomized order. In all, 109 patients were prospectively recruited. Field Strength/Sequence: 3T MRI with a standard breast protocol (dynamic-CE, T 2 w-TSE, STIR-T 2 w, DWI). Assessment: Histopathology was the standard of reference. Three blinded, off-site breast radiologists evaluated the examinations using the BI-RADS lexicon. Statistical Tests: Lesion detection, sensitivity, specificity, and diagnostic accuracy were calculated per-lesion and per-region, and compared by univariate and multivariate analysis (Generalized Estimating Equations, GEE). Results: Five patients were excluded, leaving 104 women with 142 histologically verified breast lesions (109 malignant, 33 benign) available for evaluation. Lesion detection with gadobenate (84.5-88.7%) was not inferior to gadoterate (84.5–90.8%) (P ≥ 0.165). At per-region analysis, gadobenate demonstrated higher specificity (96.4–98.7% vs. 92.6–97.3%, P ≤ 0.007) and accuracy (96.3–97.8% vs. 93.6–96.1%, P ≤ 0.001) compared with gadoterate. Multivariate analysis demonstrated superior, reader-independent diagnostic accuracy with gadobenate (odds ratio = 1.7, P < 0.001 using GEE). Data Conclusion: A 0.075 mmol/kg dose of the high-relaxivity contrast agent gadobenate was not inferior to a 0.15 mmol/kg dose of gadoterate for breast lesion detection. Gadobenate allowed increased specificity and accuracy. Level of Evidence: 1. Technical Efficacy: Stage 2. J. Magn. Reson. Imaging 2019;49:1157–1165. © 2018 International Society for Magnetic Resonance in Medicine |