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


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.


CONCLUSIONS
Gd-EOB-DTPA is an efficient, diagnostically useful, and safe contrast agent.
Reimer
P
P
Institute of Clinical Radiology, Westfalian Wilhelms-University Muenster, Germany.
Rummeny
E J
EJ
Shamsi
K
K
Balzer
T
T
Daldrup
H E
HE
Tombach
B
B
Hesse
T
T
Berns
T
T
Peters
P E
PE
D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000009:adverse effects; D019786:Gadolinium DTPA; D006801:Humans; D008099:Liver / Q000473:pathology; D008107:Liver Diseases / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000556:secondary; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D004369:Pentetic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors
D003287:Contrast Media; D009942:Organometallic Compounds; C073590:gadolinium ethoxybenzyl DTPA; D004369:Pentetic Acid; D005682:Gadolinium; D019786:Gadolinium DTPA