Radiology, Vol 199, 177-183, Copyright © 1996 by Radiological Society of North America

ARTICLES

Phase II clinical evaluation of Gd-EOB-DTPA: dose, safety aspects, and pulse sequence

P Reimer, EJ Rummeny, K Shamsi, T Balzer, HE Daldrup, B Tombach, T Hesse, T Berns and PE Peters
Institute of Clinical Radiology, Westfalian Wilhelms-University Muenster, Germany.

PURPOSE: To investigate the efficacy of gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA) in the detection of focal liver lesions with respect to dose, side effects, and pulse sequence. MATERIALS AND METHODS: A randomized double-blinded trial was performed in 33 patients with focal solid liver lesions. A bolus of Gd- EOB-DTPA, a liver-specific contrast agent, was intravenously administered at three different doses (12.5, 25, and 50 mumol per kilogram of body weight). Magnetic resonance imaging with different T1- weighted techniques was performed 20 and 45 minutes after administration of Gd-EOB-DTPA. Changes in liver signal intensity, lesion-liver contrast-to-noise ration (C/N), detectable liver lesions, side effects, and adverse events were evaluated. RESULTS: Gd-EOB-DTPA significantly (P < .05) increased liver signal intensity and lesion- liver C/N within the dose range tested. Lesion detection was improved 20 and 45 minutes after administration of Gd-EOB-DTPA. A dose of 12.5 mumol was sufficient for the detection of focal liver lesions, and the breath-hold, T1-weighted, fast low-angle shot pulse sequence was the most useful. No significant changes in vital signs, clinical laboratory test results, and urinalysis were observed. CONCLUSION: Gd-EOB-DTPA is an efficient, diagnostically useful, and safe contrast agent.

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