E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with recent diagnosis of breast cancer, histologically proven. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
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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 obtain first data on the optimal contrast media application protocol for gadobutrol-enhanced MRI for the visualization and marking of breast lesion in preparation of vacuum-assisted biopsy. |
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E.2.2 | Secondary objectives of the trial |
- to evaluate technical parameters after repeated application of gadobutrol with different doses - to evaluate saftey in terms of adverse events |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Adult patients, age 18 years and older 2) with recent diagnosis of breast cancer, histologically proven (within the last 6 weeks before inclusion) 3) referred to contrast-enhanced MRI of the breast for clinical reasons before surgery 4) willing and able to comply with and complete all study procedures 5) who provided written informed consent voluntarily and in person |
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E.4 | Principal exclusion criteria |
1) If female, being pregnant or in nursery (females of childbearing potential must have a negative urine pregnancy test at the day of MRI prior to administration of gadobutrol 2) Any contraindication to the MRI procedure (e.g., metal implants, phobia) 3) Any contraindication to gadolinium-containing MR contrast agents 4) History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents 5) Having received any contrast agent within 24 hours prior to the MRI examination planned in this study 6) Considered to be clinically unstable or risk of unpredictable clinical course during the study period (e.g., due to previous surgery, acute renal failure) 7) Severe cardiovascular disease (e.g., known long QT syndrome, acute myocardinal infraction [<14 days], unstable angina, congestive heart failure NYHA class IV) or acute stroke (<48 hours) 8) Severly or moderately impaired renal function (GFR calculated with MDRD formular </ = 60 mL/ min/ 1.72m2). Serum creatinine values must not be older than 8 weeks 9) Scheduled or likely to require surgery and/ or biopsy before MRI or within 24 hours after study drug administration 10) Participating in another diagnostic clinical trial 11) Having previously entered this study 12) Patients with a heart rate > 100/ min (measured before the MRI examination) 13) Patients with a blood pressure > Systole/ Diastole 200/ 100 mmHg (measured before the MRI-examination) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Visualization of each index breast lesion on a 4-point scale (the index lesion is assumed to be easily identifiable in MRI because of the marling with clips for subsequent surgery):
- excellent, good, moderate, poor (measured at 1, 11, 21, and 31 min) |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Gadovist as comparator in different application schemes |
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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 | No |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 15 |