patiens with breast lesions which are highly suspicious or already known for malignancy which are requested for MRI MedDRA version: 6.1 Level: PT Classification code 10006279
Conditions
Interventions
Trade Name: MULTIHANCE
Pharmaceutical Form: Solution for injection
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number: 0.05-
Trade Name: MAGNEVIST
Ph
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Is a female adult subject 18 years or older Has at least one suspicious or known breast lesion based on at least one of the following exams, performed within 30 days prior to Exam 1 - Mammography ACR BI-RADS category 3, 4 or 5 lesions - Physical examination palpable lesion . Has or will have histological diagnosis of the breast lesion s by at least one of the following - Non-surgical biopsy of the breast within 14 days but not less than 24 hours prior to Exam 1 and has no history of breast surgery; or Is scheduled for - Non-surgical breast biopsy including core needle biopsy, vacuum-assisted biopsy or large core biopsy within 14 days but not less than 2 hours after Exam 2; and/or - Breast surgery including surgical biopsy, lumpectomy and mastectomy within 30 days but not less than 24 hours after Exam 2. 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: Is a pregnant or lactating female. Exclude the possibility of pregnancy by one of the following - by Testing on site serum or urine beta-HCG within 24 hours prior to the start of each IP administration; - Surgical history e.g., tubal ligation or hysterectomy ; - Post menopausal with a minimum 1 year without menses; Has severe or end-stage organ failure, including but not limited to congestive heart failure class IV according to the New York Heart Association classification and severe renal failure; Is undergoing radiotherapy or has undergone and terminated radiotherapy in the breast of interest within 12 months before Exam 1; Is undergoing chemotherapy/antitumoral hormonal therapy, or has undergone and terminated chemotherapy/antitumoral hormonal therapy within 6 months before Exam 1; Has history of breast surgery including surgical biopsy, lumpectomy and mastectomy ; Has received or scheduled to receive any other contrast medium, either intra-vascularly or orally, within 24 hours before through 24 hours after each IP injection for both Exam 1 and Exam 2; Has previously been entered into this study or has received an investigational drug within 30 days prior to Exam 1; Has pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field; Suffers from severe claustrophobia; Has known allergy to one or more of the ingredients of the IPs MULTIHANCE and MAGNEVIST and/or a history of hypersensitivity to any metals and/or chelates of gadolinium; Has any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving the study objectives or completing the study; Has a medical condition or associated illness that makes it unlikely that all the required procedures of the study would be completed; Is determined by the Investigator that the subject is clinically unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the superiority of MULTIHANCE 0.1 mmol/kg over the same dose of MAGNEVIST for breast MRI in terms of sensitivity for the diagnosis of malignant lesions compared with histopathology.;Secondary Objective: To compare the 0.1 mmol/kg dose of MULTIHANCE with the 0.1 mmol/kg dose of MAGNEVIST for breast MRI for the diagnosis of breast cancer compared with truth standard findings in terms of - Sensitivity, specificity, accuracy, positive predictive value and negative predicative value at both quadrant, breast and at subjectlevels; - Inter-reader agreement in determining the nature of the lesions To compare the 0.1 mmol/kg dose of MULTIHANCE with the 0.1 mmol/kg dose of MAGNEVIST for breast MRI in terms of - Qualitative and quantitative assessment of contrast between breast lesions and normal parenchyma; - Qualitative assessment of border delineation of lesions; and - Global diagnostic preference of the blinded readers To confirm the previously established safety profile of a single dose 0.1 mmol/kg of MULTIHANCE in comparison with MAGNEVIST at the same dose for MRI of the breast;Primary end point(s): sensitivity for the diagnosis MRI of malignant lesions compared with histopathology. | — |
Countries
Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed