Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging. The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics. The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
293
Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
DRZ Die Radiologen
Regensburg, Bavaria, Germany
Radiologisches Institut Universitätsklinikum Erlangen
Erlangen, Germany
Stichting Martini Ziekenhuis
Groningen, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis. Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.
Time frame: one year
Collect data for comfort of CE-BCT and CE-MRI
The secondary objective is to collect data for comfort of CE-BCT and CE-MRI using a patient questionnaire of closed questions. The questionnaire asks in 7 categories for 1. Overall rating of the examination 2. Comfort of the device during examination 3. The feel of the operating noise of the device 4. The rating of the space provided by the device 5. The duration of the examination 6. The question if the patient would agree to have the examination again, if necessary with the device 7. After both modalities which diagnostic method would be the preference, MRI or BCT. Every question can be rated with 5 possible ratings from very good to very bad or adapted possibilities like pleasantly quit to unpleasantly loud.
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.