Completed PHASE3 INTERVENTIONAL 1-arm NCT01067976

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist®) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI

Sponsor: Bayer

Conditions Breast Cancer Diagnostic Imaging

Interventions Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Updated 7 times since 2017 Last updated: Nov 10, 2014 Started: Feb 28, 2010 Primary completion: Jul 31, 2011 Completion: Jan 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Breast Cancer and Diagnostic Imaging and is currently completed. Bayer leads this study, which shows 7 recorded versions since 2010 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Feb 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bayer

Data source: Bayer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ansan Si, Kyungki Do, South Korea , Baden, Switzerland , Barranquilla, Colombia , Bern, Switzerland , Bielefeld, Germany , Bogotá, Colombia , Boston, United States , Buenos Aires, Argentina , Chur, Switzerland , Dortmund, Germany and 23 more locations