Breast tumor MedDRA version: 9.1 Level: LLT Classification code 10006192 Term: Breast cancer NOS
Conditions
Interventions
Trade Name: Gadovist 1.0 mmol/ml
Product Code: V08C A09
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobutrol
CAS Number: 138071-82-6
Concentration unit: mmol/ml millimole(s)/mil
Sponsors
Charité Campus Mitte
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age: 18-70 years • female • histologically proven breast tumor or suspected benign and malignant lesions, biopsy performed or planned • willing to undergo all study procedures • having personally signed and dated the informed consent form 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: • Patients who are in (or are suspected of) pregnancy or nursery. In women of child bearing potential a pregnancy test must be performed before inclusion in this study • Patients with any physical or mental status that interferes with the signing of informed consent • any contraindication for MRI • having received any contrast material within 12 hours prior to injection with study or comparator drug. • requiring emergency treatment • Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault or MDRD formula. Calculation of the clearance must be done before begin of study. • Patients who are scheduled for breast surgery or who would have a biopsy prior to the second planned injection of contrast medium • History of anaphylactoid or anaphylactic reaction to any contrast media • Having been previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the non-inferiority of gadobutrol (Gadovist®; 0.1 mmol/kg body weight) compared to gadopentetate dimeglumine (Magnevist®; 0.1 mmol/kg body weight) regarding the quantitative assessment of the peak maximum enhancement in breast lesions.;Secondary Objective: Assessment of the degree/difference in • quantitative assessment of time-to-peak, upslope, time to 100% enhancement [(SIpost – Sipre)/SIpre] *100 and washout • qualitative assessment: Lesion conspicuity (margin, intensity, homogeneity) • peak enhancement of the target lesion at 5 minutes after application of Gadovist® and Dotarem® and at the delayed phase. • To assess the value of DWI and MRS before and after contrast agent application for characterization of breast lesions • Further histopathological workup of the biopsy or post-operating tissue will be performed including ex vivo spectroscopy. ;Primary end point(s): The primary efficacy variable is the peak enhancement 1 minute after contrast medium application and refers to T1-weighted GRE measurement of the target lesion after contrast compared to the measurement of the lesion pre-contrast. | — |
Countries
Germany
Outcome results
None listed