DCIS Clinical Trial
— CEMinDCISOfficial title:
The Added Value of Contrast Enhanced Mammography (CEM) to Standard Mammography in Assessing the Extent of Ductal Carcinoma in Situ (DCIS)
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 1, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. - Patients/subjects whose CEMs do not correspond to the diagnostic interpretation for technical reasons are excluded from the study: insufficient positioning, contrast agent extravasation, failed subtraction - Patients under 18 years of age |
Country | Name | City | State |
---|---|---|---|
Croatia | Clinical Hospital Centre Rijeka | Rijeka | Primorsko Goranska County |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Center Rijeka |
Croatia,
Covington MF, Pizzitola VJ, Lorans R, Pockaj BA, Northfelt DW, Appleton CM, Patel BK. The Future of Contrast-Enhanced Mammography. AJR Am J Roentgenol. 2018 Feb;210(2):292-300. doi: 10.2214/AJR.17.18749. Epub 2017 Oct 24. — View Citation
Covington MF. Contrast-Enhanced Mammography Implementation, Performance, and Use for Supplemental Breast Cancer Screening. Radiol Clin North Am. 2021 Jan;59(1):113-128. doi: 10.1016/j.rcl.2020.08.006. Epub 2020 Oct 29. — View Citation
Klaric K, Sribar A, Budisavljevic A, Labinac L, Valkovic Zujic P. Evaluation of Contrast-Enhanced Mammography and Development of Flowchart for BI-RADS Classification of Breast Lesions. Diagnostics (Basel). 2023 Jun 3;13(11):1958. doi: 10.3390/diagnostics1 — View Citation
Kuhl CK, Strobel K, Bieling H, Wardelmann E, Kuhn W, Maass N, Schrading S. Impact of Preoperative Breast MR Imaging and MR-guided Surgery on Diagnosis and Surgical Outcome of Women with Invasive Breast Cancer with and without DCIS Component. Radiology. 2017 Sep;284(3):645-655. doi: 10.1148/radiol.2017161449. Epub 2017 Apr 26. — View Citation
Sardanelli F, Trimboli RM, Houssami N, Gilbert FJ, Helbich TH, Alvarez Benito M, Balleyguier C, Bazzocchi M, Bult P, Calabrese M, Camps Herrero J, Cartia F, Cassano E, Clauser P, Cozzi A, de Andrade DA, de Lima Docema MF, Depretto C, Dominelli V, Forrai G, Girometti R, Harms SE, Hilborne S, Ienzi R, Lobbes MBI, Losio C, Mann RM, Montemezzi S, Obdeijn IM, Ozcan UA, Pediconi F, Pinker K, Preibsch H, Raya Povedano JL, Sacchetto D, Scaperrotta GP, Schiaffino S, Schlooz M, Szabo BK, Taylor DB, Ulus OS, Van Goethem M, Veltman J, Weigel S, Wenkel E, Zuiani C, Di Leo G. Magnetic resonance imaging before breast cancer surgery: results of an observational multicenter international prospective analysis (MIPA). Eur Radiol. 2022 Mar;32(3):1611-1623. doi: 10.1007/s00330-021-08240-x. Epub 2021 Oct 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 years | |
Primary | 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 | 3 years | |
Primary | 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 | 3 years | |
Primary | 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 | 3 years | |
Primary | True positive rate of CEM vs. MMG (Sensitivity) | True positive rate = Number of true positive / (Number of true positive + Number of false negative) | 3 years | |
Primary | True negative rate of CEM vs. MMG (Specificity) | True negative rate = Number of true negative / (Number of true negative + Number of false positive) | 3 years | |
Primary | False positive rate of CEM vs. MMG (overestimation) | False positive rate = Number of false positive / (Number of false positive + Number of true negative) | 3 years | |
Primary | False negative rate of CEM vs. MMG (underestimation) | False negative rate= Number of false negative / (Number of false negative + Number of true positive) | 3 years | |
Primary | Accuracy of CEM vs. MMG | Accuracy = (Number of true positive + Number of true negative) / (Number of true positive+ Number of false positive + Number of true negative + Number of false negative) | 3 years | |
Primary | Inadequate surgical margins rate in the Interventional Group | Percentage of patients with inadequate surgical margins (<2mm) | 3 years | |
Primary | Inadequate surgical margins rate in the Control Group | Percentage of patients with inadequate surgical margins (<2mm) | 3 years | |
Primary | Re-operation rate in the Interventional Group | Percentage of repeated surgical procedures in breast | 3 years | |
Primary | Re-operation rate in the Control Group | Percentage of repeated surgical procedures in breast | 3 years | |
Primary | Mastectomy rate in the Interventional Group | Percentage of patients with mastectomy | 3 years | |
Primary | Mastectomy rate in the Control Group | Percentage of patients with mastectomy | 3 years | |
Secondary | 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) | 3 years | |
Secondary | 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) | 3 years | |
Secondary | 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 | 3 years | |
Secondary | 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 | 3 years | |
Secondary | Lesion extension of high-grade DCIS (G3) on CEM | Size of the lesion determined in millimetres. | 3 years | |
Secondary | Lesion extension of low-grade DCIS (G1-2) on CEM | Size of the lesion determined in millimetres. | 3 years | |
Secondary | Background parenchymal enhancement associated with high-grade DCIS (G3) on CEM | Background parenchymal enhancement (symmetric or asymmetric) is categorized as minimal, mild, moderate and marked. | 3 years | |
Secondary | Background parenchymal enhancement associated with low grade DCIS (G1-2) on CEM | Background parenchymal enhancement (symmetric or asymmetric) is categorized as minimal, mild, moderate and marked. | 3 years | |
Secondary | Distribution of NME associated with high-grade DCIS (G3) on CEM | Non-mass enhancement (NME) classified as: focal, linear, segmental, regional, multiple regions or diffuse. | 3 years | |
Secondary | Distribution of NME associated with low grade DCIS (G1-2) on CEM | Non-mass enhancement (NME) classified as: focal, linear, segmental, regional, multiple regions or diffuse. | 3 years | |
Secondary | Lesion conspicuity associated with high-grade DCIS (G3) on CEM | Lesion conspicuity (relative to background) is the degree of enhancement compared to background, described as low, moderate or high | 3 years | |
Secondary | Lesion conspicuity associated with low grade DCIS (G1-2) on CEM | Lesion conspicuity (relative to background) is the degree of enhancement compared to background, described as low, moderate or high | 3 years | |
Secondary | Morphologic features of mass lesion associated with high-grade DCIS (G3) on CEM | Mass lesions are defined by shape and margin: descriptors for mass shape and margin include oval, round, or irregular shape, with circumscribed or not circumscribed (irregular, spiculated) margin. | 3 years | |
Secondary | Morphologic features of mass lesion associated with low grade DCIS (G1-2) on CEM | Mass lesions are defined by shape and margin: descriptors for mass shape and margin include oval, round, or irregular shape, with circumscribed or not circumscribed (irregular, spiculated) margin. | 3 years | |
Secondary | Internal pattern of enhancement of mass lesion associated with high-grade DCIS (G3) on CEM | Internal pattern can be homogeneous, heterogeneous, or rim enhancement. | 3 years | |
Secondary | Internal pattern of enhancement of mass lesion associated low grade DCIS (G1-2) on CEM | Internal pattern can be homogeneous, heterogeneous, or rim enhancement. | 3 years | |
Secondary | Overall treatment cost in the Interventional Group | All costs related to diagnostic workup and related to surgical treatment will be evaluated for each patient (costs of the procedure, hospital days, readmission rate after the first treatment). | 3 years | |
Secondary | Overall treatment cost in the Control Group | All costs related to diagnostic workup and related to surgical treatment will be evaluated for each patient (costs of the procedure, hospital days, readmission rate after the first treatment). | 3 years |
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