Safety and efficacy of Omniscan (R) (gadodiamide injection) at 0.1 mmol/kgfor MRI in infants younger than 6 months of age - Phase III open multicenter study
L. Marti-bonmati et al., Safety and efficacy of Omniscan (R) (gadodiamide injection) at 0.1 mmol/kgfor MRI in infants younger than 6 months of age - Phase III open multicenter study, INV RADIOL, 35(2), 2000, pp. 141-147
Citations number
14
Categorie Soggetti
Radiology ,Nuclear Medicine & Imaging","Medical Research Diagnosis & Treatment
RATIONALE AND OBJECTIVES. To demonstrate that gadodiamide injection is a sa
fe and efficient contrast agent for MRI in infants younger than 6 months of
age.
METHODS. The authors designed a phase III multicenter nonrandomized study u
sing a control group. Gadodiamide injection at a dosage of 0.1 mmol/kg body
weight was administered to 39 children; 20 received no contrast. The mean
age was 10.6 weeks in the contrast group and 9.3 weeks in the control group
. MR examinations, blood (serum creatinine, S-ASAT, S-ALAT, S-bilirubin, al
kaline phosphatase) and urine (proteins, blood, others) sampling before sed
ation and after examination, heart rate (electrocardiography) and oxygen sa
turation (pulse oximetry) during examination, adverse events, and efficacy
parameters were analyzed.
RESULTS. In the contrast group, 18 (51.4%) children had 31 abnormal changes
in one or more of the safety parameters and vital signs. In the control gr
oup there were 16 (80.0%) children with 19 abnormal changes. Gadodiamide in
jection had no negative influence on the safety parameters. No serious adve
rse events occurred, and only three clinically relevant adverse events (ele
vation of S-ALAT and S-ASAT, elevation of bilirubin) in two patients in the
contrast group and one event (vomiting) in one patient in the control grou
p were documented, The benefit of the contrast medium was clearly shown for
all evaluated parameters.
CONCLUSIONS. Gadodiamide injection is safe, well tolerated, and effective i
n infants younger than 6 months of age.