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NCT02540967 Clinical Trial

Drug Use Investigation of Gadovist.

Magnetic Resonance Imaging Clinical Trial

Official title:
Drug Use Investigation of Gadovist

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02540967
Other study ID # 17512
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 27, 2015
Est. completion date November 2, 2017

Study information
Verified date November 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Description:

This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study). The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited. For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).

Recruitment information / eligibility
Status Completed
Enrollment 3357
Est. completion date November 2, 2017
Est. primary completion date November 2, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist. Exclusion Criteria: - Patients who are contraindicated based on approved label.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Gadovist dosage following summary of product characteristics

Locations
Country Name City State
Japan Many Locations Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of episodes of adverse events as a measure of safety and tolerability Up to 3 days
Secondary Number of episodes of adverse drug reactions and adverse events In subpopulations Up to 3 days
Secondary Contrast enhancement Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.
MRI- Magnetic Resonance Imaging		 At the time of MRI
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