Safety Efficacy of Gadodiamide Injection Administered Intravenously to Children for Contrast-Enhanced MR of the Central Nervous System

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Abstract

Rationale and Objectives. The lower osmolality of gadodiamide injection than gadopentetate dimeglumine (Gd-DTPA) contributes to gadodiamide having a higher median lethal dose in mice and rats. However, proof of safety and efficacy of gadodiamide has been derived largely from adult studies. To assess the performance of gadodiamide in pediatric central nervous system imaging, a study of 187 pediatric patients was performed. Methods. Part 1 of the study compared gadodiamide and Gd-DTPA in 174 children from 2 to 18 years of age. In part 2, 13 patients under the age of 2 were evaluated with gadodiamide alone. The majority of patients in both parts of the study were evaluated for possible neoplasm. Results. The difference in the incidence of adverse events between gadodiamide and Gd-DTPA showed an important trend. Three percent of gadodiamide-treated patients reported adverse events, whereas 9% did so in the Gd-DTPA group. Both agents were equally effective in terms of providing added diagnostic value: 76% for gadodiamide and 75% for Gd-DTPA. Conclusion. Gadodiamide and Gd-DTPA are equally effective in detecting lesions, and gadodiamide is at least equal in safety to Gd-DTPA at a dose of 0.1 mmol/kg in the pediatric population from birth to 18 years of age.

Original languageEnglish (US)
Pages (from-to)S15-S22
JournalAcademic Radiology
Volume1
DOIs
StatePublished - 1994
Externally publishedYes

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gadodiamide
Gadolinium DTPA
Central Nervous System
Safety
Injections
Pediatrics

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

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title = "Safety Efficacy of Gadodiamide Injection Administered Intravenously to Children for Contrast-Enhanced MR of the Central Nervous System",
abstract = "Rationale and Objectives. The lower osmolality of gadodiamide injection than gadopentetate dimeglumine (Gd-DTPA) contributes to gadodiamide having a higher median lethal dose in mice and rats. However, proof of safety and efficacy of gadodiamide has been derived largely from adult studies. To assess the performance of gadodiamide in pediatric central nervous system imaging, a study of 187 pediatric patients was performed. Methods. Part 1 of the study compared gadodiamide and Gd-DTPA in 174 children from 2 to 18 years of age. In part 2, 13 patients under the age of 2 were evaluated with gadodiamide alone. The majority of patients in both parts of the study were evaluated for possible neoplasm. Results. The difference in the incidence of adverse events between gadodiamide and Gd-DTPA showed an important trend. Three percent of gadodiamide-treated patients reported adverse events, whereas 9{\%} did so in the Gd-DTPA group. Both agents were equally effective in terms of providing added diagnostic value: 76{\%} for gadodiamide and 75{\%} for Gd-DTPA. Conclusion. Gadodiamide and Gd-DTPA are equally effective in detecting lesions, and gadodiamide is at least equal in safety to Gd-DTPA at a dose of 0.1 mmol/kg in the pediatric population from birth to 18 years of age.",
author = "Latchaw, {Richard E}",
year = "1994",
doi = "10.1016/S1076-6332(12)80028-6",
language = "English (US)",
volume = "1",
pages = "S15--S22",
journal = "Academic Radiology",
issn = "1076-6332",
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T1 - Safety Efficacy of Gadodiamide Injection Administered Intravenously to Children for Contrast-Enhanced MR of the Central Nervous System

AU - Latchaw, Richard E

PY - 1994

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N2 - Rationale and Objectives. The lower osmolality of gadodiamide injection than gadopentetate dimeglumine (Gd-DTPA) contributes to gadodiamide having a higher median lethal dose in mice and rats. However, proof of safety and efficacy of gadodiamide has been derived largely from adult studies. To assess the performance of gadodiamide in pediatric central nervous system imaging, a study of 187 pediatric patients was performed. Methods. Part 1 of the study compared gadodiamide and Gd-DTPA in 174 children from 2 to 18 years of age. In part 2, 13 patients under the age of 2 were evaluated with gadodiamide alone. The majority of patients in both parts of the study were evaluated for possible neoplasm. Results. The difference in the incidence of adverse events between gadodiamide and Gd-DTPA showed an important trend. Three percent of gadodiamide-treated patients reported adverse events, whereas 9% did so in the Gd-DTPA group. Both agents were equally effective in terms of providing added diagnostic value: 76% for gadodiamide and 75% for Gd-DTPA. Conclusion. Gadodiamide and Gd-DTPA are equally effective in detecting lesions, and gadodiamide is at least equal in safety to Gd-DTPA at a dose of 0.1 mmol/kg in the pediatric population from birth to 18 years of age.

AB - Rationale and Objectives. The lower osmolality of gadodiamide injection than gadopentetate dimeglumine (Gd-DTPA) contributes to gadodiamide having a higher median lethal dose in mice and rats. However, proof of safety and efficacy of gadodiamide has been derived largely from adult studies. To assess the performance of gadodiamide in pediatric central nervous system imaging, a study of 187 pediatric patients was performed. Methods. Part 1 of the study compared gadodiamide and Gd-DTPA in 174 children from 2 to 18 years of age. In part 2, 13 patients under the age of 2 were evaluated with gadodiamide alone. The majority of patients in both parts of the study were evaluated for possible neoplasm. Results. The difference in the incidence of adverse events between gadodiamide and Gd-DTPA showed an important trend. Three percent of gadodiamide-treated patients reported adverse events, whereas 9% did so in the Gd-DTPA group. Both agents were equally effective in terms of providing added diagnostic value: 76% for gadodiamide and 75% for Gd-DTPA. Conclusion. Gadodiamide and Gd-DTPA are equally effective in detecting lesions, and gadodiamide is at least equal in safety to Gd-DTPA at a dose of 0.1 mmol/kg in the pediatric population from birth to 18 years of age.

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