Patients with histologically confirmed breast cancer referred to MRM prior to surgery after XRM. MedDRA version: 12.0 Level: LLT Classification code 10012992 Term: Digital mammography
Conditions
Interventions
Trade Name: Gadovist® 1.0 mmol/ml, solution for injection
Product Name: Gadovist® 1.0 mmol/ml, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadobutrol
CAS Nu
Sponsors
Bayer Health Care AG (study performed by Bayer Schering Pharma AG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is at least 18 years of age. 2. Has recent histologically proven diagnosis of breast cancer after having obtained 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 MRM prior to surgery of the breast. 3. 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 (based on the quantitative criteria for the BI-RADS mammographic density categories of 51%–75% for heterogeneously dense, and >75% dense for the extremely dense category); c. Is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation). 4. Is willing to undergo the contrast-enhanced MRM examinations with gadobutrol. 5. Is willing and able to complete all study procedures specified in the protocol. 6. If female, patient is either not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test within 1 hour prior to the administration of gadobutrol. 7. If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle. 8. Has an estimated glomerular filtration rate (eGFR) value = 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment. 9. Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate in writing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Is a female patient who is pregnant or lactating. 2. Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study. 3. Has been previously enrolled in this study. 4. Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents. 5. Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents. 6. 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. 7. Is considered clinically unstable or his/her clinical course during the study period is unpredictable (e.g., due to previous surgery, acute renal failure). 8. 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)). 9. 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/1.73m2). 10. Has received chemotherapy or hormonal therapy for breast cancer within 6 months. 11. Has received hormone replacement therapy within 4 weeks prior to study drug administration. 12. Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application 13. Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to demonstrate: 1. Superiority of combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM 2. Superiority of combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM Based on the categorical accuracy in determination of the extent of malignant breast disease on breast region level with 3 categories (unifocal, multifocal malignant disease or no malignant disease present) and verified by the predefined SoT (histopathology or alternatively XRM plus ultrasound) ;Secondary Objective: 1. Combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM 2. Combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM 3. Combined unenhanced and gadobutrol-enhanced MRM plus XRM versus XRM alone Based on: • Categorical accuracy by descriptive statistics using breast regions with SoT based on histology only • Sensitivity and specificity for malignant breast disease on breast region level for disease / no disease • Sensitivity and specificity for unifocal malignant breast disease on breast region level for unifocal disease / no unifocal disease • Sensitivity and specificity for multifocal malignant breast disease on breast region level for multifocal disease / no multifocal disease • Accuracy of the presence of the multicentric malignant disease “Yes/No” per breast • Accuracy of the presence of bilateral malignant disease “Yes/No” per patient • Confidence in diagnosis on breast region level;Primary end point(s): The primary objectives of this study are to demonstrate: 1. Superiority of combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM 2. Superiority of combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM Based on the categorical accuracy in determination of the extent of malignant breast disease on breast region level with 3 categories (unifocal, multifocal malignant disease or no malignant dise | — |
Countries
Finland, Germany, Italy
Outcome results
None listed