Phase 3
N=460
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01104584 ↗Enrolled (actual)
460
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader — 15.2; 31.9; 30.4; 15.9 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
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader |
15.2; 31.9; 30.4; 15.9 | — |
| PRIMARY Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader |
88.6; 73.3; 89.0; 57.0; 85.5; 55.1 | — |
| PRIMARY Breast Level Specificity of CMRM for Non-malignant Breasts by Reader |
91.8; 83.9; 82.8; 95.4 | — |
| SECONDARY Breast Level Specificity of CMRM Based on Malignant Breasts |
54.9; 47.2; 55.5; 93.8 | — |
| SECONDARY Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM |
15.5; 19.8; -1.0; 30.2; 13.9; -1.3 | — |
| SECONDARY Percentage Difference of Participants Whose Additional Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM |
23.8; 42.9; 0.0; 44.0; 48.8; 0.0 | — |
| SECONDARY Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Reader, Participant Level |
0.97; 1.25; -0.23; 0.95; 0.74; 0.04 | — |
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:
- a. patient is younger than 50 years;
- b. patient has heterogeneously or extremely dense breasts;
- c. 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 (NCT01104584). 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.