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

Abstract

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.

• Authors: Laura Martincich, Matthieu Faivre-Pierret, Christian M Zechmann, Stefano Corcione, Harrie C M van den Bosch, Wei-Jun Peng, Antonella Petrillo, Katja C Siegmann, Johannes T Heverhagen, Pietro Panizza, Hans-Björn Gehl, Felix Diekmann, Federica Pediconi, Lin Ma, Fiona J Gilbert, Francesco Sardanelli, Paolo Belli, Marco Salvatore, Karl-Friedrich Kreitner, Claudia M Weiss, Chiara Zuiani
• Journal: Radiology (Radiology) Vol. 258 Issue 2 Pg. 396-408 (Feb 2011) ISSN: 1527-1315 [Electronic] United States
• PMID: 21163915 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Contrast Media
• Organometallic Compounds
• gadobenic acid
• Meglumine
• Gadolinium DTPA

Topics

• Adult
• Aged
• Aged, 80 and over
• Breast Neoplasms (diagnosis, pathology)
• Chi-Square Distribution
• China
• Contrast Media
• Cross-Over Studies
• Double-Blind Method
• Europe
• Female
• Gadolinium DTPA
• Humans
• Image Interpretation, Computer-Assisted
• Magnetic Resonance Imaging (methods)
• Meglumine (analogs & derivatives)
• Middle Aged
• Organometallic Compounds
• Predictive Value of Tests
• Prospective Studies
• Sensitivity and Specificity