Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI) (GEMMA 2)
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
Listed as NCT01104584, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Bayer, it has been updated 7 times since 2010, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
May 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bayer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Alzira, Spain , Barcelona, Spain , Berlin, Germany , Bochum, Germany , Buenos Aires, Argentina , Bydgoszcz, Poland , Chicago, United States , Columbus, United States , Córdoba, Spain , Delhi, India and 30 more locations