NCT01411449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,030

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2015

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

August 5, 2011

Last Update Submit

March 16, 2017

Conditions

Diagnostic Imaging

Keywords

PrimovistMRI agent

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist

    After Primovist injection, up to 7 days

  • Incidence of adverse drug reactions in patients with renal impairment

    After Primovist injection, up to 7 days

Secondary Outcomes (2)

  • Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]

    After Primovist injection, up to 7 days

  • MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired

    After Primovist injection, up to 7 days

Study Arms (1)

Group 1

Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Interventions

Gadoxetic Acid Disodium (Primovist, BAY86-4873)DRUG

Patients who will need to undergo contrast enhanced MRI with Primovist

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population of this study is patients who received Primovist for liver MRI. The study is expected to collect data of 2,000 patients in about 150 hospitals in Japan.

You may qualify if:

  • Patients who received Primovist for liver MRI

You may not qualify if:

  • Patients who are contraindicated based on the product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Interventions

gadolinium ethoxybenzyl DTPA

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

March 11, 2008

Primary Completion

December 14, 2010

Study Completion

February 18, 2015

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

JP(1)