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NCT01104584 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
NCT01104584: Completed Phase 3 study, sponsored by Bayer.
NCT01104584 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01104584, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers
Primary Outcome
For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammog
Interventions
- DRUG Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01104584 record still lists
NCT01104584 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Gadobutrol (Gadavist, Gadovist, BAY86-4875) is the first listed.
NCT01104584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01104584 about?
NCT01104584 is a clinical study titled "Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)". The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect addi...
What is the current status of trial NCT01104584?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2010-05. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01104584?
The interventions under investigation include: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (DRUG).
Who is sponsoring clinical trial NCT01104584?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01104584's enrollment target sits among peer trials
460 823rd of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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