MH 109 - A Study You Can't Afford To Ignore

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Contrast Enhancement of Central Nervous System Lesions: Multicenter Intraindividual Crossover Comparative Study of Two MR Contrast Agents
Kenneth R. Maravilla, Joseph A. Maldjian, Ilona M. Schmalfuss, Matthew J. Kuhn, Brian C. Bowen, Franz J. Wippold II, Val M. Runge, Michael V. Knopp, Stephane Kremer, Leo J. Wolansky, Nicoletta Anzalone, Marco Essig, and Lars Gustafsson
Radiology 2006 240 (2) Abstract

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Related abstracts from the 2005 Radiological Society of North America (RSNA) annual meeting.

Maravilla KR, Maldjian JA, Schmalfuss IM, et al.
Contrast-enhanced MR Imaging of CNS Lesions: Results of a Large Scale Intraindividual Crossover Comparison of Gadobenate Dimeglumine versus Gadopentetate Dimeglumine (abstr). In: Radiological Society of North American Scientific Assembly and Annual Meeting Program. Oak Brook, Ill: Radiological Society of North America, 2005; 387-388.

PURPOSE
To compare a 0.1 mmol/kg dose of the higher-relaxivity gadolinium agent gadobenate dimeglumine (GD-BOPTA) with an equivalent dose of gadopentetate dimeglumine (Gd-DTPA) for enhanced MR imaging of CNS lesions using a multicenter, double-blind, randomized, intra-individual, crossover design.

METHOD AND MATERIALS
151 patients referred for MRI of the brain or spine underwent two MRI examinations at 1.5 T, one enhanced with GD-BOPTA at 0.1 mmol/kg and the other with Gd-DTPA at the same dose. Contrast injection was performed in a blinded and fully randomized manner with an interval of 2–7 days between administrations. Imaging parameters were identical for the two examinations: pre-dose T1wSE and T2wFSE sequences; an identical T1wSE sequence post-dose (at 3–7 min post-dose, but precisely equivalent post-dose acquisition time for the two examinations in each patient). Images were evaluated by three independent and fully blinded neuroradiologists in terms of diagnostic information (lesion border delineation, definition of disease extent, visualization of lesion internal morphology, lesion contrast enhancement, global diagnostic preference) and quantitative (% lesion enhancement, contrast-to-noise ratio [CNR]) parameters. Preferences were evaluated using scales containing objective image interpretation criteria for the selected endpoints. Between group comparisons were performed (Wilcoxon signed rank test) and inter-reader agreement (weighted kappa statistics) determined.

RESULTS
Out of the 151 patients enrolled, readers 1, 2 and 3 demonstrated global diagnostic information preference for GD-BOPTA in 75, 89 and 103 patients, respectively, compared with 7, 10 and 6 patients for Gd-DTPA (p<0.0001; all readers). Similarly highly significant (p<0.0001; all readers, all comparisons) preference for GD-BOPTA was demonstrated for all individual diagnostic information endpoints, for % lesion enhancement and for CNR. Inter-reader (3-reader) agreement was good for all evaluations (kappa values from 0.43 to 0.57).

CONCLUSION
The higher relaxivity agent, GD-BOPTA, provides significantly better contrast enhancement and diagnostic information compared to Gd-DTPA at equivalent dose.

Maldjian JA, Essig M, Anzalone N, et al.
Intraindividual Crossover Comparison of Gadobenate Dimeglumine and Gadopentetate Dimeglumine for Visualization and Assessment of Intra-axial Brain Tumors (abstr). In: Radiological Society of North American Scientific Assembly and Annual Meeting Program. Oak Brook, Ill: Radiological Society of North America, 2005, 388.

PURPOSE
To compare the enhancement of intra-axial CNS lesions obtained with 0.1 mmol/kg gadobenate dimeglumine (GD-BOPTA) or 0.1 mmol/kg gadopentetate dimeglumine (Gd-DTPA).

METHOD AND MATERIALS
A multicenter, double-blind, randomized, crossover comparison was conducted in 92 patients with primary or secondary intra-axial brain tumors, each undergoing two MR examinations at 1.5 T, one with GD-BOPTA and one with Gd-DTPA according to a fully randomized sequence attribution order, with 2–7 days between administrations. T1wSE and T2wFSE sequences were acquired pre-dose with post-dose repetition of the T1wSE sequence at a fixed time-point (same post-dose acquisition time for the two examinations in each patient) and using the same acquisition parameters. Three experienced, fully blinded readers independently evaluated all images in terms of degree and quality of diagnostic information (lesion border delineation, definition of disease extent, visualization of lesion internal morphology, lesion contrast enhancement, global diagnostic preference) and quantitative parameters (% lesion enhancement, contrast-to-noise ratio). Differences were tested statistically with the Wilcoxon signed rank test. Reader agreement was assessed using weighted kappa statistics.

RESULTS
All readers noted significantly (p<0.0001) better diagnostic information and contrast enhancing performance for GD-BOPTA compared to Gd-DTPA for all lesion visualization endpoints and quantitative determinations. Readers 1, 2 and 3 considered contrast enhancement and diagnostic information to be superior in 48 (52%), 58 (63%) and 61 (66%) patients, respectively, after GD-BOPTA compared with 4 (4%), 5 (5%) and 3 (3%) patients after Gd-DTPA (p<0.0001). Similar differences were noted for all other determinations. Agreement between the three readers was good (kappa > 0.4, all determinations).

CONCLUSION
The higher relaxivity agent, GD-BOPTA, permits significantly improved delineation of lesion borders, definition of tumor extent, visualization of lesion internal morphology and lesion contrast enhancement compared to Gd-DTPA at equivalent dose, potentially enabling improved patient management and pre-surgical planning.