Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial)
| Autor: | Antonella Petrillo, Matthieu Faivre-Pierret, Paolo Belli, K.-F. Kreitner, Francesco Sardanelli, Federica Pediconi, L. Martincich, Johannes T. Heverhagen, Pietro Panizza, Marco Salvatore, Claudia M. Weiss, Katja C. Siegmann, Fiona J. Gilbert, Chiara Zuiani, Stefano Corcione, Christian M. Zechmann, Hans B. Gehl, Harrie C. M. van den Bosch, Wei Jun Peng, Felix Diekmann, Lin Ma |
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| Přispěvatelé: | Martincich, L, Faivre Pierret, M, Zechmann, Cm, Corcione, S, van den Bosch, Hc, Peng, Wj, Petrillo, A, Siegmann, Kc, Heverhagen, Jt, Panizza, P, Gehl, Hb, Diekmann, F, Pediconi, F, Ma, L, Gilbert, Fj, Sardanelli, F, Belli, P, Salvatore, Marco, Kreitner, Kf, Weiss, Cm, Zuiani, C. |
| Rok vydání: | 2010 |
| Předmět: |
Adult
Gadolinium DTPA China Contrast Media Breast Neoplasms Sensitivity and Specificity law.invention Double blind breast neoplasm contrast media MRI Breast cancer Meglumine breast neoplasm Randomized controlled trial Double-Blind Method law Predictive Value of Tests Image Interpretation Computer-Assisted medicine Organometallic Compounds Humans Radiology Nuclear Medicine and imaging Prospective Studies Prospective cohort study GADOBENATE DIMEGLUMINE Aged Aged 80 and over Chi-Square Distribution Cross-Over Studies business.industry Middle Aged medicine.disease Mr imaging Crossover study Magnetic Resonance Imaging Europe Female Breast disease Nuclear medicine business MRI |
| Zdroj: | Radiology. 258(2) |
| ISSN: | 1527-1315 |
| Popis: | 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.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.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.Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. © RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/).http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1. |
| Databáze: | OpenAIRE |
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