DCISCEMinDCISNCT06217458
The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS
A study testing Contrast Enhanced Mammography in people with DCIS and Breast Carcinoma in Situ, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- DCIS, Breast Carcinoma in Situ, Calcification
- What is being tested?
- Contrast Enhanced Mammography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Mar 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
Clinical Hospital Centre Rijeka
Rijeka, Primorsko Goranska County, 51000
Petra Valkovic Zujic, PhD, +38598713493
Ana Car Peterko, +385989798103, anacarpeterko@gmail.com
About this study
Official 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.
Read the detailed description
Ductal carcinoma in situ (DCIS) is the earliest form of malignant lesion in the breast, which in most cases is diagnosed by mammography screening, usually in the form of asymptomatic calcifications. The question of whether DCIS is a true malignancy of the breast, which pathological criteria are used for diagnosing and classifying DCIS, but also the questions of the nature of the disease and its overtreatment are controversial. Surgery is still the primary treatment of DCIS, and the status of the surgical margins is of paramount importance. Compared to invasive ductal carcinoma, the re-excision rate in DCIS is relatively high (30-40%), probably because the change is not palpable. Segmental distribution, with areas affected by the disease that are not calcified and therefore not detected, and stricter guidelines for appropriate surgical margins may also contribute to the re-excision rate. Because the diagnosis of DCIS is closely associated with mammographic detection of pathologic calcifications, it was assumed that magnetic resonance (MR) imaging would provide little or no value for their detection and visualization. However, a study conducted by Kuhl et al. showed that breast MRI has a significantly higher sensitivity than mammography in detecting DCIS. In addition, subsequent studies have shown that MRI is more accurate than mammography in assessing the distribution of DCIS. In recent years, mammography with an iodine contrast agent, known as contrast mammography (CEM), has been introduced, which, like MRI, is based on the evaluation of tumor angiogenesis. It is important to emphasize that the sensitivity of CEM in detecting malignant lesions corresponds to the sensitivity of MR. CEM has several advantages over breast MRI, the most important of which are the availability and the shorter imaging time, as well as the shorter time required to analyze the mammogram and read the findings. Numerous studies show that patients tolerate CEM better than MRI.
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. The interventional cohort involves 50 consecutive patients with newly diagnosed DCIS who will undergo surgery at CHC Rijeka in 2024, 2025, and 2026 and who agree to have a CEM performed before surgery as part of the diagnostic work-up in addition to standard mammography and who agree to participate in the trial. Patients diagnosed with ductal in situ carcinoma who underwent surgery at CHC Rijeka in the period from 2019 to 2024 and whose clinical data are available in the prospectively managed clinical register for breast diseases at CHC Rijeka and the Integrated Hospital Informatics System (IBIS), are included in the second (control) cohort.
Two clinical radiology specialists with experience in breast radiology will evaluate the morphologic and functional features of standard MMG and CEM by consensus, and assess the extent of disease using the BI-RADS lexicon for imaging with contrast mammography. Demographic and imaging data (morphological and functional characteristics on CME such as background parenchymal enhancement, presence/absence of a lesion, location of the lesion in breast quadrant, type of lesion, size of the lesion in mm and BI-RADS category are analyzed for each lesion) will be recorded. Only one lesion per breast is considered, and if multiple lesions are visible, the overall diameter of the suspicious area will be considered. The above parameters are compared with the grade of the DCIS tumor, i. e. the morphological and functional characteristics of G1 and G2 lesions compared to G3 lesions.
- Conditions
- DCIS, Breast Carcinoma in Situ, Calcification
- Being tested
- Contrast Enhanced Mammography
- Keywords
- Ductal in situ carcinoma, Calcifications, Breast surgery, Screening, Contrast Enhanced Mammography
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced MammographyDiagnostic test
Also called CEM
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Patients with mammographically newly detected ductal in situ carcinoma who undergo surgery at CHC Rijeka in 2024, 2025, and 2026 (consecutively), who agree to have a CEM performed prior to surgery as part of the diagnostic work-up in addition to standard mammography, and who agree to participate in the examination. Group number: 50 patients. Receives: Diagnostic Test: Contrast Enhanced Mammography |
| Historical Control | No intervention | Patients diagnosed with ductal in situ carcinoma who underwent surgery at CHC Rijeka in the period from 2019 to 2024 and whose clinical data are available in the prospectively managed clinical registry for breast diseases at CHC Rijeka and in the Hospital Information System (IBIS). Group number: 50 patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
True positive rate of CEM vs. MMG (Sensitivity)
True positive rate = Number of true positive / (Number of true positive + Number of false negative)
Measured: 3 years
True negative rate of CEM vs. MMG (Specificity)
True negative rate = Number of true negative / (Number of true negative + Number of false positive)
Measured: 3 years
False positive rate of CEM vs. MMG (overestimation)
False positive rate = Number of false positive / (Number of false positive + Number of true negative)
Measured: 3 years
False negative rate of CEM vs. MMG (underestimation)
False negative rate= Number of false negative / (Number of false negative + Number of true positive)
Measured: 3 years
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)
Measured: 3 years
Inadequate surgical margins rate in the Interventional Group
Percentage of patients with inadequate surgical margins (<2mm)
Measured: 3 years
Inadequate surgical margins rate in the Control Group
Percentage of patients with inadequate surgical margins (<2mm)
Measured: 3 years
Re-operation rate in the Interventional Group
Percentage of repeated surgical procedures in breast
Measured: 3 years
Re-operation rate in the Control Group
Percentage of repeated surgical procedures in breast
Measured: 3 years
Mastectomy rate in the Interventional Group
Percentage of patients with mastectomy
Measured: 3 years
Mastectomy rate in the Control Group
Percentage of patients with mastectomy
Measured: 3 years
Secondary outcomes (18)
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)
Measured: 3 years
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)
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
Lesion extension of high-grade DCIS (G3) on CEM
Size of the lesion determined in millimetres.
Measured: 3 years
Lesion extension of low-grade DCIS (G1-2) on CEM
Size of the lesion determined in millimetres.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Internal pattern of enhancement of mass lesion associated with high-grade DCIS (G3) on CEM
Internal pattern can be homogeneous, heterogeneous, or rim enhancement.
Measured: 3 years
Internal pattern of enhancement of mass lesion associated low grade DCIS (G1-2) on CEM
Internal pattern can be homogeneous, heterogeneous, or rim enhancement.
Measured: 3 years
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).
Measured: 3 years
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DCISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Valkovic Zujic, Clinical Hospital Center Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217458
- Sponsor's protocol ID
- The added value of CEM
- Acronym
- CEMinDCIS
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29064748Covington 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.
PubMed 33222993Kuhl 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.
PubMed 28445683Sardanelli 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.
PubMed 34643778Klaric 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/diagnostics13111958.
PubMed 37296810
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Contrast Enhanced Mammography (CEM) to Standard Mammography in Assessing the Extent of Ductal Carcinoma in Situ (DCIS)
- ClinicalTrials.gov ID
- NCT06217458
- Acronym / sponsor ID
- CEMinDCIS / The added value of CEM
- Conditions
- DCIS, Breast Carcinoma in Situ, Calcification
- Keywords
- Ductal in situ carcinoma, Calcifications, Breast surgery, Screening, Contrast Enhanced Mammography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ductal carcinoma in situ (DCIS) is the earliest form of malignant lesion in the breast, which in most cases is diagnosed by mammography screening, usually in the form of asymptomatic calcifications. The question of whether DCIS is a true malignancy of the breast, which pathological criteria are used for diagnosing and classifying DCIS, but also the questions of the nature of the disease and its overtreatment are controversial. Surgery is still the primary treatment of DCIS, and the status of the surgical margins is of paramount importance. Compared to invasive ductal carcinoma, the re-excision rate in DCIS is relatively high (30-40%), probably because the change is not palpable. Segmental distribution, with areas affected by the disease that are not calcified and therefore not detected, and stricter guidelines for appropriate surgical margins may also contribute to the re-excision rate. Because the diagnosis of DCIS is closely associated with mammographic detection of pathologic calcifications, it was assumed that magnetic resonance (MR) imaging would provide little or no value for their detection and visualization. However, a study conducted by Kuhl et al. showed that breast MRI has a significantly higher sensitivity than mammography in detecting DCIS. In addition, subsequent studies have shown that MRI is more accurate than mammography in assessing the distribution of DCIS. In recent years, mammography with an iodine contrast agent, known as contrast mammography (CEM), has been introduced, which, like MRI, is based on the evaluation of tumor angiogenesis. It is important to emphasize that the sensitivity of CEM in detecting malignant lesions corresponds to the sensitivity of MR. CEM has several advantages over breast MRI, the most important of which are the availability and the shorter imaging time, as well as the shorter time required to analyze the mammogram and read the findings. Numerous studies show that patients tolerate CEM better than MRI.
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. The interventional cohort involves 50 consecutive patients with newly diagnosed DCIS who will undergo surgery at CHC Rijeka in 2024, 2025, and 2026 and who agree to have a CEM performed before surgery as part of the diagnostic work-up in addition to standard mammography and who agree to participate in the trial. Patients diagnosed with ductal in situ carcinoma who underwent surgery at CHC Rijeka in the period from 2019 to 2024 and whose clinical data are available in the prospectively managed clinical register for breast diseases at CHC Rijeka and the Integrated Hospital Informatics System (IBIS), are included in the second (control) cohort.
Two clinical radiology specialists with experience in breast radiology will evaluate the morphologic and functional features of standard MMG and CEM by consensus, and assess the extent of disease using the BI-RADS lexicon for imaging with contrast mammography. Demographic and imaging data (morphological and functional characteristics on CME such as background parenchymal enhancement, presence/absence of a lesion, location of the lesion in breast quadrant, type of lesion, size of the lesion in mm and BI-RADS category are analyzed for each lesion) will be recorded. Only one lesion per breast is considered, and if multiple lesions are visible, the overall diameter of the suspicious area will be considered. The above parameters are compared with the grade of the DCIS tumor, i. e. the morphological and functional characteristics of G1 and G2 lesions compared to G3 lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Diagnostic Test: Contrast Enhanced MammographyPatients with mammographically newly detected ductal in situ carcinoma who undergo surgery at CHC Rijeka in 2024, 2025, and 2026 (consecutively), who agree to have a CEM performed prior to surgery as part of the diagnostic work-up in addition to standard mammography, and who agree to participate in the examination. Group number: 50 patients. |
| Historical Control | No intervention | –Patients diagnosed with ductal in situ carcinoma who underwent surgery at CHC Rijeka in the period from 2019 to 2024 and whose clinical data are available in the prospectively managed clinical registry for breast diseases at CHC Rijeka and in the Hospital Information System (IBIS). Group number: 50 patients. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced MammographyAlso: CEMThe 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. | Diagnostic test | Interventional Group |
Primary outcome
Number of true positive CEMs in the Interventional group
Time frame: 3 years
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
Time frame: 3 years
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
Time frame: 3 years
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
Time frame: 3 years
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
True positive rate of CEM vs. MMG (Sensitivity)
Time frame: 3 years
True positive rate = Number of true positive / (Number of true positive + Number of false negative)
True negative rate of CEM vs. MMG (Specificity)
Time frame: 3 years
True negative rate = Number of true negative / (Number of true negative + Number of false positive)
False positive rate of CEM vs. MMG (overestimation)
Time frame: 3 years
False positive rate = Number of false positive / (Number of false positive + Number of true negative)
False negative rate of CEM vs. MMG (underestimation)
Time frame: 3 years
False negative rate= Number of false negative / (Number of false negative + Number of true positive)
Accuracy of CEM vs. MMG
Time frame: 3 years
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)
Inadequate surgical margins rate in the Interventional Group
Time frame: 3 years
Percentage of patients with inadequate surgical margins (<2mm)
Inadequate surgical margins rate in the Control Group
Time frame: 3 years
Percentage of patients with inadequate surgical margins (<2mm)
Re-operation rate in the Interventional Group
Time frame: 3 years
Percentage of repeated surgical procedures in breast
Re-operation rate in the Control Group
Time frame: 3 years
Percentage of repeated surgical procedures in breast
Mastectomy rate in the Interventional Group
Time frame: 3 years
Percentage of patients with mastectomy
Mastectomy rate in the Control Group
Time frame: 3 years
Percentage of patients with mastectomy
18 secondary outcomes
Estimated percentage of breast resection volume based on CEM
Time frame: 3 years
Estimated percentage of breast resection volume based on MMG
Time frame: 3 years
Duration of complete preoperative diagnostic workup in the Intervention Group
Time frame: 3 years
Duration of complete preoperative diagnostic workup in the Control Group
Time frame: 3 years
Lesion extension of high-grade DCIS (G3) on CEM
Time frame: 3 years
Lesion extension of low-grade DCIS (G1-2) on CEM
Time frame: 3 years
Background parenchymal enhancement associated with high-grade DCIS (G3) on CEM
Time frame: 3 years
Background parenchymal enhancement associated with low grade DCIS (G1-2) on CEM
Time frame: 3 years
Distribution of NME associated with high-grade DCIS (G3) on CEM
Time frame: 3 years
Distribution of NME associated with low grade DCIS (G1-2) on CEM
Time frame: 3 years
Lesion conspicuity associated with high-grade DCIS (G3) on CEM
Time frame: 3 years
Lesion conspicuity associated with low grade DCIS (G1-2) on CEM
Time frame: 3 years
Morphologic features of mass lesion associated with high-grade DCIS (G3) on CEM
Time frame: 3 years
Morphologic features of mass lesion associated with low grade DCIS (G1-2) on CEM
Time frame: 3 years
Internal pattern of enhancement of mass lesion associated with high-grade DCIS (G3) on CEM
Time frame: 3 years
Internal pattern of enhancement of mass lesion associated low grade DCIS (G1-2) on CEM
Time frame: 3 years
Overall treatment cost in the Interventional Group
Time frame: 3 years
Overall treatment cost in the Control Group
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 29064748Covington 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.
- Background: PubMed 33222993Covington 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.
- Background: PubMed 28445683Kuhl 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.
- Background: PubMed 34643778Sardanelli 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.
- Results publication: PubMed 37296810Klaric 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/diagnostics13111958.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Mammography in people with DCIS and Breast Carcinoma in Situ, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Valkovic Zujic, PhD (+98598713493, petra.valkovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of true positive CEMs in the Interventional group (time frame: 3 years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217458, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.