Comparison of gadobenate dimeglumine-enhanced breast MRI and gadopentetate dimeglumine-enhanced breast MRI with mammography and ultrasound for the detection of breast cancer.

PURPOSE: To compare gadobenate dimeglumine-enhanced magnetic resonance imaging (MRI) with gadopentetate dimeglumine-enhanced MRI, mammography, and ultrasound for breast cancer detection across different malignant lesion types and across different densities of breast tissue. MATERIALS AND METHODS: In all, 153 women with Breast Imaging Reporting and Data System (BI-RADS) 3­5 findings on mammography and/or ultrasound underwent identical breast MRI exams at 1.5T with gadobenate dimeglumine and gadopentetate dimeglumine. Images were evaluated by three independent blinded radiologists. Mammography, ultrasound, and combined mammography and/or ultrasound findings were available for 108, 109, and 131 women. Imaging findings were matched with histology data by a fourth, independent, blinded radiologist. Malignant lesion detection rates and diagnostic performance were compared. RESULTS: In all, 120, 120, and 140 confirmed malignant lesions were present in patients undergoing MRI+mammography, MRI+ultrasound, and MRI+mammography and/or ultrasound, respectively. Significantly greater cancer detection rates were noted by all three readers for comparisons of gadobenate dimeglumine-enhanced MRI with mammography (Δ15.8­17.5%; P < 0.0001), ultrasound (Δ18.3­20.0%; P < 0.0001), and mammography and/or ultrasound (Δ8.6­10.7%; P ≤ 0.0105) but not for comparisons of gadopentetate dimeglumine-enhanced MRI with conventional techniques (P > 0.05). The false-positive detection rates were lower on gadobenate dimeglumine-enhanced MRI than on conventional imaging (4.0­5.5% vs. 11.1% at mammography; 6.3­8.4% vs. 15.5% at ultrasound). Significantly improved cancer detection on MRI was noted in heterogeneously dense breast (91.2­97.3% on gadobenate dimeglumine-enhanced MRI vs. 77.2­84.9% on gadopentetate dimeglumine-enhanced MRI vs. 71.9-84.9% with conventional techniques) and for invasive cancers (93.2­96.2% for invasive ductal carcinoma [IDC] on gadobenate dimeglumine-enhanced MRI vs. 79.7­88.5% on gadopentetate dimeglumine-enhanced MRI vs. 77.0­84.4% with conventional techniques). Overall diagnostic performance for the detection of cancer was superior on gadobenate dimeglumine-enhanced MRI than on conventional imaging or gadopentetate dimeglumine-enhanced MRI. CONCLUSION: Gadobenate dimeglumine-enhanced MRI significantly improves cancer detection compared to gadopentetate dimeglumine-enhanced MRI, mammography, and ultrasound in a selected group of patients undergoing breast MRI for preoperative staging or because of inconclusive findings at conventional imaging.

Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial).

PURPOSE: To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol. MATERIALS AND METHODS: Institutional review board approval and patient informed consent were obtained. One hundred sixty-two women (mean age, 52.8 years ± 12.3 [standard deviation]) enrolled at 17 sites in Europe and China between July 2007 and May 2009 underwent at least one breast MR imaging examination at 1.5 T by using three-dimensional spoiled gradient-echo sequences. Of these, 151 women received both contrast agents in randomized order in otherwise identical examinations separated by more than 2 but less than 7 days. Images, acquired at 2-minute or shorter intervals after contrast agent injection, were evaluated independently by three blinded radiologists unaffiliated with enrollment centers. Histopathologic confirmation was available for all malignant lesions (n = 144), while benign lesions were confirmed either by using histopathologic examination (n = 52) or by at least 12-month diagnostic follow-up (n = 20) with mammography and/or ultrasonography. Determinations of malignant lesion detection rates and diagnostic performance (sensitivity, specificity, accuracy, positive predictive value [PPV], and negative predictive value [NPV]) were performed and compared (McNemar and Wald tests). A full safety assessment was performed. RESULTS: Significant superiority for gadobenate dimeglumine was noted by readers 1, 2, and 3 for malignant lesion detection rate (91.7%, 93.1%, 94.4% vs 79.9%, 80.6%, 83.3%, respectively; P ≤ .0003). Readers 1, 2, and 3 reported significantly superior diagnostic performance (sensitivity, specificity, and accuracy) for breast cancer detection with gadobenate dimeglumine (91.1%, 94.5%, 95.2% vs 81.2%, 82.6%, 84.6%; 99.0%, 98.2%, 96.9% vs 97.8%, 96.9%, 93.8%; 98.2%, 97.8%, 96.7% vs 96.1%, 95.4%, 92.8%, respectively; P ≤ .0094) and significantly superior PPV (91.1%, 85.2%, 77.2% vs 80.7%, 75.5%, 60.9%, respectively; P ≤ .0002) and NPV (99.0%, 99.4%, 99.4% vs 97.8%, 98.0%, 98.1%, respectively; P ≤ .0003). No safety concerns were noted with either agent. CONCLUSION: Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. © RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/). SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1.

Fibromuscular dysplasia of the main renal arteries: comparison of contrast-enhanced MR angiography with digital subtraction angiography.

PURPOSE: To retrospectively evaluate the sensitivity and specificity of contrast material-enhanced magnetic resonance (MR) angiography by using digital subtraction angiography as the reference standard in patients with hypertension and renal artery fibromuscular dysplasia (FMD). MATERIALS AND METHODS: Institutional review board approval was obtained, with waiver of informed consent. The results of renal contrast-enhanced MR angiography were retrospectively analyzed in 25 patients with hypertension (24 women, one man; mean age, 48 years +/- 19 [standard deviation]; age range, 18-72 years) who had FMD diagnosed on the basis of clinical and angiographic features. All examinations were performed at 1.5 T. Results were analyzed by two readers, and a third reader established a consensus in case of discrepancy. Sensitivity, specificity, and 95% confidence intervals (CIs) were calculated for FMD and for each possible type of FMD lesion ("string of pearls" appearance, stenosis, and aneurysm). A linear-weighted kappa statistic was calculated to determine agreement between digital subtraction angiography and contrast-enhanced MR angiography for the diagnosis of FMD and to determine inter- and intraobserver agreement regarding FMD diagnosis. RESULTS: Fifty main renal arteries were analyzed, 35 of which demonstrated abnormal arteriographic features of FMD (stenosis, 22 arteries; string of pearls, 21 arteries; and aneurysm, four arteries). The sensitivity and specificity of contrast-enhanced MR angiography for the diagnosis of FMD were 97% (95% CI: 83%, 100%) and 93% (95% CI: 66%, 100%), respectively. Sensitivity was 68% (95% CI: 83%, 100%), 95% (95% CI: 74%, 100%), and 100% (95% CI: 40%, 100%) for the diagnosis of stenosis, string of pearls, and aneurysm, respectively. Linear-weighted kappa statistics for inter- and intraobserver agreement regarding FMD diagnosis were 0.63 and 0.92, respectively. CONCLUSION: In patients with renal FMD, contrast-enhanced MR angiography can reliably facilitate diagnosis by demonstrating characteristic lesions.