The study hypothesis is that the rate of inadequate surgical margins after conservative breast surgery for DICS and the rate of reoperation (re-excision or/and mastectomy) is lower in the group of patients who underwent standard preoperative mammography and CEM to assess the extent of DICS, compared to the group of patients for whom the preoperative assessment of the extent of in situ breast cancer was not performed using one of the imaging techniques with contrast medium such as contrast mammography or magnetic resonance imaging.
Patients with pathohistological diagnosis of ductal in situ carcinoma based on samples obtained by vacuum-assisted breast biopsy (VABB) or ultrasound-guided breast biopsy (CNB)
Presented at the meeting of the multidisciplinary breast team of the Clinical Hospital Center in Rijeka
Patients who underwent surgery at CHC Rijeka and whose pathohistological diagnosis in the final PH report was pure DCIS or microinvasive breast cancer (DCIS with microinvasion)
Patients who agree to participate in the study
Patients with contraindications for CEM: renal insufficiency (which is ruled out by presenting creatinine and/or eGFR results), iodine allergy, pregnancy/lactation, hyperthyroidism
Patients who have undergone a preoperative breast MRI
Patients who have both DCIS and invasive carcinoma in the preoperative PH report or the final PH report of the surgical material, with the exception of foci with microinvasion (< 1 mm).
Patients with ipsilateral DCIS recurrence or with previous ipsilateral breast surgery for invasive cancer.
Factorial
Contrast Enhanced Mammography
Diagnostic testThe CEM performance protocol involves the intravenous administration of non-ionic, low-osmolarity iodinated contrast medium using an automatic syringe that delivers the required bolus of contrast medium at a dose of 1.5 ml/kg body weight at a rate of 3 ml/s without compressing the breast. After a two-minute pause, necessary to allow the breast parenchyma to absorb (stain) the contrast agent, the patient is positioned for the mammogram and the breast is compressed. First the symptomatic and then the non-symptomatic breast is imaged in two or a total of four standard projections: craniocaudal (CC) and oblique mediolateral (MLO) projections of the breast. The delayed CC and MLO projections of the symptomatic breast are taken within eight minutes of the start of the examination. The delayed mammograms are used to assess the dynamics of the contrast uptake of the lesion and are compared to the same parameters of the breast MRI. The time required to perform the CEM is 8-10 minutes.
Number of true positive CEMs in the Interventional group
Number of patients in whom the estimated size of DCIS (longest diameter in mm) is larger on CEM than on MMG and in whom the actual size in PH report is greater than the size on estimated on MMG
Number of false positive CEMs in the Interventional Group
Number of patients in whom the estimated size of DCIS (longest diameter in mm) on CEM is larger than on MMG, but the size in the PH report correlates better with the size estimated on MMG
Number of true negative CEMs in the Interventional Group
Number of patients with no difference in the radiological assessment of the size of DCIS (longest diameter in mm), and in whom the size in the PH report correlates with the size on MMG
Number of false negative CEMs in the Interventional Group
Number of patients with no difference in the radiological assessment of the size of DCIS (longest diameter in mm is similar on CEM and MMG), but in whom the size in the PH report is greater than the size on MMG and CEM
Estimated percentage of breast resection volume based on CEM
Percentage of breast resection volume based on CEM findings according to the formula (4 x (radius of the lesion + 1 cm)3 ) : (radius of the breast 2 x projection of the breast)
Estimated percentage of breast resection volume based on MMG
Percentage of breast resection volume based on MMG findings according to the formula (4 x (radius of the lesion + 1 cm)3 ) : (radius of the breast 2 x projection of the breast)
Duration of complete preoperative diagnostic workup in the Intervention Group
Number of days between the date of the first clinical examination at CHC Rijeka (surgeon or radiologist) and the date of surgery
Duration of complete preoperative diagnostic workup in the Control Group
Number of days between the date of the first clinical examination at CHC Rijeka (surgeon or radiologist) and the date of surgery
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