Clinical trial · Interventional
The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS
The Added Value of Contrast Enhanced Mammography (CEM) to Standard Mammography in Assessing the Extent of Ductal Carcinoma in Situ (DCIS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma in Situ | Breast Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Calcification | — | UNRESOLVED | — |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Mammography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Group
- description
- 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.
- interventionNames
- Diagnostic Test: Contrast Enhanced Mammography
- type
- NO_INTERVENTION
- label
- Historical Control
- description
- 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.
Primary outcomes (15)
- measure
- Number of true positive CEMs in the Interventional group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDCovington 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. PMID 29064748
- BACKGROUNDCovington 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. PMID 33222993
- BACKGROUNDKuhl 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. PMID 28445683
- BACKGROUNDSardanelli 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. PMID 34643778
- RESULTKlaric 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. PMID 37296810