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Contrast kinetics in dynamic contrast-enhanced MRI of the breast in patients with histologically proven breast cancers with and without a computer aided detection system.


- candidate number21199
- NTR NumberNTR4956
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-dec-2014
- Secondary IDs14-N-118 
- Public TitleContrast kinetics in dynamic contrast-enhanced MRI of the breast in patients with histologically proven breast cancers with and without a computer aided detection system.
- Scientific TitleContrast kinetics of Gadobutrol in dynamic contrast-enhanced MRI of the breast in patients with histologically proven breast cancers initially classified as BIRADS 5 with and without a computer aided detection system.
- ACRONYM
- hypothesisThe goal of this exploratory study is to directly compare quantitative enhancement parameters (the contrast agent kinetics) between 1.0 molar Gadobutrol with and without the utilisation of a Computer Aided Detection system (CAD) in patients with histologically proven breast cancers initially classified as BIRADS 5, undergoing dynamic contrast-enhanced MRI of the breasts.
- Healt Condition(s) or Problem(s) studiedMagnetic resonance imaging (MRI) , Breast cancer, Gadobutrol, Computer Aided Detection system
- Inclusion criteria•At least 18 years of age •Histologically proven breast cancer (BIRADS 5) •Patients who are willing to undergo study procedures
- Exclusion criteria•Patients who have previously entered this study •Patients who are or are suspected in pragnancy or nursery •Patients with a contraindication for MRI •Patients who have received any contrast material within 48 hours prior to injection with study or comparator drug. •Patients who require 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 formula. Calculation of the clearance must be done before begin of study. •Patients with known anaphylactoid or anaphylactic reaction to any contrast media
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-jan-2015
- planned closingdate1-jan-2016
- Target number of participants30
- InterventionsNone
- Primary outcomeThe initial rate of enhancement, the maximum enhancement, and the percentage decrease in enhancement in the signal intensity-time curves measured at the last time point relative to the maximum enhancement within the first 120 seconds post contrast agent administration will be determined with and without the use of the CAD-system.
- Secondary outcomeInterobserver variability with and without the use of the CAD-system will be determined
- TimepointsDynamic contrast-enhanced MRI of the breasts will be reported in daily practice by breast radiologists. Data collection for this study will be performed in separate sessions for the manual collected enhancement characteristics and the CAD assisted enhancement characteristics. The researchers will be blinded to the patient data. Statistical analysis will be performed after all patients have been included.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES M. Junghans
- CONTACT for SCIENTIFIC QUERIES M. Junghans
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad , Bayer, NL
- Publications
- Brief summaryRationale When performing a MRI scan of a breast lesion, dynamic contrast-enhanced series are important for lesion characterization by providing information about the rate and shape of enhancement of the lesion over time. These signal intensity-time curves can add value in differentiating malignant from benign lesions. Signal intensity-time curves are commonly presented as a single curve for a specific region of interest. Another method is to analyse and quantify the contrast enhancement in every pixel over time and present the results as a colour-coded map. The goal of this exploratory study is to directly compare quantitative enhancement parameters (the contrast agent kinetics) between 1.0 molar Gadobutrol with and without the utilisation of a Computer Aided Detection system (CAD) in patients with histologically proven breast cancers initially classified as BIRADS 5, undergoing dynamic contrast-enhanced MRI of the breasts.
- Main changes (audit trail)
- RECORD30-dec-2014 - 27-feb-2015


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