Phase 3
N=446
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
Breast Cancer · Diagnostic Imaging
Bottom Line
View on ClinicalTrials.gov: NCT01067976 ↗Enrolled (actual)
446
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader — 46.6; 30.8; 23.3; 17.8 difference in sensitivity (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader |
46.6; 30.8; 23.3; 17.8 | — |
| PRIMARY Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader |
36.6; 83.2; 49.1; 79.9; 63.4; 86.7 | — |
| PRIMARY Breast Level Specificity of CMRM for Non-malignant Breasts by Reader |
85.6; 95.0; 88.6; 95.4 | — |
| SECONDARY Breast Level Specificity of CMRM Based on Malignant Breasts |
61.1; 59.4; 58.5; 90.3 | — |
| SECONDARY Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM |
47.9; 11.8; 0.0; 30.9; 13.1; -3.4 | — |
| SECONDARY Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM |
42.5; 36.8; -2.3; 25.3; 29.9; 0.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
- If female, a digital XRM is required if any of the following criteria is met:
- patient is younger than 50 years;
- patient has heterogeneously or extremely dense breasts;
- is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
- If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
- Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Exclusion Criteria
- Is a female patient who is pregnant or lactating
- Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
- Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
- Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
- Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).
- Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
- Has received hormone replacement therapy within 4 weeks prior to study drug administration.
- Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
- Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM
Data sourced from ClinicalTrials.gov (NCT01067976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.