Abstract

This study compares ferucarbotran-enhanced magnetic resonance (MR) imaging with spiral computed tomography (CT) in the clinical management of patients with suspected hepatic malignancy. One hundred fifty-nine patients with suspected liver malignancy were included in a prospective, multicenter, phase IIIB clinical trial. Patients were examined with baseline plus contrast-enhanced spiral CT and with baseline plus ferucarbotran-enhanced MR imaging. For each patient, four maps of liver lesions were constructed by a trusted blind party on the basis of (a) baseline plus contrast-enhanced spiral CT, (b) baseline MR imaging, (c) baseline plus ferucarbotran-enhanced MR imaging, and (d) final diagnosis. Three blinded experts evaluated the treatment options for each map. The concordance of the treatment choice based on imaging with the treatment choice based on final diagnosis was verified. The final therapeutic decision was radical therapy for 85 patients, palliative therapy for 49 patients, and no treatment for 25 patients who had a final diagnosis of benign lesion. Proper treatment allocation was achieved in 121 (76%) of 159 patients when the evaluation was based on liver maps obtained from spiral CT, in 97 (61%) of 159 patients when the evaluation was based on liver maps obtained from baseline MR imaging, and in 136 (85%) of 159 patients when the evaluation was based on liver maps obtained from baseline plus ferucarbotran-enhanced MR imaging. MR imaging with ferucabotran was significantly superior to spiral CT for correct treatment allocation (P = 0.0167). Ferucarbotran-enhanced MR imaging is superior to spiral CT in clinical management of patients with suspected hepatic malignancy.

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