E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patiens with breast lesions which are highly suspicious or already known for malignancy which are requested for MRI |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006279 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
sensitivity for the diagnosis MRI of malignant lesions compared with histopathology. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |