Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients

Sung Bum Cho, A. Leum Lee, Hyuk Won Chang, Kyeong Ah Kim, Won Jong Yoo, Jeong A. Yeom, Myung Ho Rho, Sung Jin Kim, Yun jung Lim, Miran Han

    Research output: Contribution to journalArticlepeer-review

    5 Citations (Scopus)


    Background: The safety of gadolinium-based contrast agents is of fundamental importance. Purpose: To determine the frequency and severity of immediate-type adverse reactions to approved doses of gadoteridol in patients referred for routine gadoteridol-enhanced MRI in actual clinical practice settings. Study Type: Prospective, observational. Population: In all, 6163 subjects were enrolled (mean age: 56.7 ± 15.4 years; range: 6–93 years). Field Strength/Sequence: 1.5T and 3.0T. Assessment: Assessment was of immediate adverse reactions by the investigating radiologist using the MedDRA System Organ Class and preferred term. Statistical Tests: Summary statistics for continuous variables, descriptive statistics for demographic characteristics. Results: Overall, 19 adverse events occurred in 13 (0.21%) patients, of which 15 in 10 (0.16%) patients were considered related to gadoteridol administration. These events were evenly distributed between male and female subjects and all occurred in adults. Twelve of the 15 related events in eight (0.13%) patients were considered mild in intensity (rapidly self-resolving), while the remaining three events in two patients (0.03%) were considered moderate in intensity. None were of severe intensity and no serious adverse events occurred. Data Conclusion: The rate of immediate-type adverse events following exposure to approved doses of gadoteridol is extremely low, and mostly limited to transient and self-resolving symptoms. Level of Evidence: 2. Technical Efficacy Stage: 5. J. Magn. Reson. Imaging 2020;51:861–868.

    Original languageEnglish
    Pages (from-to)861-868
    Number of pages8
    JournalJournal of Magnetic Resonance Imaging
    Issue number3
    Publication statusPublished - 2020 Mar 1

    Bibliographical note

    Funding Information:
    This was a prospective, observational study involving nonselective, continuous enrollment of patients referred for contrast‐enhanced (CE)‐MRI with gadoteridol during routine daily clinical practice. It was an Institutional Review Board‐approved, Health Insurance Portability and Accountability Act‐compliant study that evaluated safety data for patients enrolled at 19 centers in South Korea between 31 December 2014 and 8 May 2018. All patients provided written informed consent for inclusion in the study. The study was sponsored by Bracco Diagnostics (Monroe, NJ).

    Publisher Copyright:
    © 2019 The Authors. Journal of Magnetic Resonance Imaging published by Wiley Periodicals, Inc. on behalf of International Society for Magnetic Resonance in Medicine.


    • adverse reactions
    • contrast agent safety
    • gadolinium-based contrast agents
    • gadoteridol
    • prospective, observational studies

    ASJC Scopus subject areas

    • Radiology Nuclear Medicine and imaging


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