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Safety data were assessed for acute\/subacute adverse events in the 48 h following gadoteridol administration and, when available, vital signs, electrocardiogram (ECG) and clinical laboratory values obtained from blood samples taken from 48\u00a0h before until 48 h following the MRI exam. The efficacy of gadoteridol-enhanced MRI compared to unenhanced MRI for disease diagnosis was evaluated prospectively by three blinded, unaffiliated readers.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Thirteen changes of laboratory values (11 mild, 1 moderate, 1 unspecified) were reported as adverse events in 7 (5.6%) patients. A relationship to gadoteridol was deemed possible though doubtful for two of these adverse events in two patients (1.6%). There were no clinical adverse events, no serious adverse events and no clinically meaningful changes in vital signs or ECG recordings. Accurate differentiation of tumor from non-neoplastic disease, and exact matching of specific MRI-determined diagnoses with on-site final diagnoses, was achieved in significantly more patients by each reader following the evaluation of combined pre- and post-contrast images compared to pre-contrast images alone (84.6\u201388.0% vs. 70.9\u201376.9%; <jats:italic>P<\/jats:italic>\u22640.006 and 67.5\u201379.5% vs. 47.0\u201366.7%; <jats:italic>P<\/jats:italic>\u22640.011, respectively).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Gadoteridol at 0.1\u00a0mmol\/kg body weight is safe, well tolerated and effective for contrast-enhanced MRI of the CNS in children \u22642\u00a0years of age.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00247-021-05069-w","type":"journal-article","created":{"date-parts":[[2021,5,5]],"date-time":"2021-05-05T06:02:37Z","timestamp":1620194557000},"page":"1895-1906","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2\u00a0years of age and younger"],"prefix":"10.1007","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8549-0202","authenticated-orcid":false,"given":"Chetan C.","family":"Shah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Vittoria","family":"Spampinato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hemant A.","family":"Parmar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osama A.","family":"Raslan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Tom\u00e0","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doris D. 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