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Primovist Post-marketing Surveillance in Japan

NCT01411449 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2030

Last updated 2017-03-17

No results posted yet for this study

Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.

Conditions

  • Diagnostic Imaging

Interventions

DRUG

Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Patients who will need to undergo contrast enhanced MRI with Primovist

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-11
Primary Completion
2010-12-14
Completion
2015-02-18

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01411449 on ClinicalTrials.gov