Patients with recent diagnosis of breast cancer, histologically proven. MedDRA version: 12.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Sponsors
Kliniken Essen-Mitte
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) 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 [ 100/ min (measured before the MRI examination) 13) Patients with a blood pressure > Systole/ Diastole 200/ 100 mmHg (measured before the MRI-examination)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: - to evaluate technical parameters after repeated application of gadobutrol with different doses - to evaluate saftey in terms of adverse events;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) | — |
Countries
Germany
Outcome results
None listed