E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Suspected or known breast cancer in females |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006188 |
E.1.2 | Term | Breast cancer female NOS |
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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 superiority of a 0.1 mmol/kg dose of the contrast medium MultiHance over a 0.1 mmol/kg dose of the contrast medium Magnevist for breast magnetic resonance imaging (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 |
1. 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 a) sensitivity, specificity, accuracy, positive predictive value and negative predicative value at breast region level, at breast level and at subject level; and b) inter-reader agreement in determining the nature of the lesions. 2. 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 a) qualitative and quantitative assessment of contrast between breast lesions and normal parenchyma; b) qualitative assessment of border delineation of lesions; and c) global diagnostic preference of the blinded readers. 3. To confirm the previously established safety profile of a single dose (0.1 mmol/kg) of MultiHnace in comparison with Magnevist at the same dose for breast MRI. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written Informed Consent and willingness to comply with protocol requirements/ Female of 18 years of age or older/ At least one suspicious or known breast lesion based on mammography (ACR BI-RADS category 3, 4 or 5 lesions) and/or ultrasonography (ACR BI-RADS category 3, 4 or 5 lesions) performed within 30 days prior to examination 1/ Planned to undergo histological diagnosis of the breast lesion(s) by 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 examination 2; and/or breast surgery (including surgical biopsy, lumpectomy and mastectomy) within 30 days but not less than 24 hours after examination 2 |
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E.4 | Principal exclusion criteria |
Body weight >100 Kg/ Pregnant or lactating/ Severe or end-stage organ failure, including but not limited to congestive heart failure (NYHA class IV)/ Moderate to severe renal impairment defined as having GFR/eGFR < 60 mL/min/ Is undergoing radiotherapy or has undergone and terminated radiotherapy in the breast of interest within 18 months before examination 1/ Is undergoing chemotherapy or antitumoral hormonal therapy, or has undergone and terminated chemotherapy or antitumoral hormonal therapy within 6 months before examination 1/ History of breast surgery (including surgical biopsy, lumpectomy and mastectomy) for malignant lesion(s) within 2 years before examination 1 and for benign lesion(s) within 1 year before examination 1/ Has received or scheduled to receive any other contrast medium within 24 hours before through 24 hours after each IP injection for both, examination 1 and examination 2/ Has previously been entered into this study or has received an investigational drug within 30 days prior to examination 1/ Has pacemakers, metallic cardiac valves, other magnetic material 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 investigational products or has a history of hypersensitivity to any metals and/or chelates of gadolinium |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity with the hypothesis of superiority of MultiHance over Magnevist for breast magnetic resonance imaging (MRI) in the diagnosis of breast cancer. Only lesions confirmed as malignant by histopathology will contribute to the primary analysis |
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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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |