The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS

NCT06217458 | Not Yet Recruiting DMC

• 1 other identifier: The added value of CEM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

DCIS; Breast Carcinoma in Situ; Calcification

Keywords

Ductal in situ carcinoma; Calcifications; Breast surgery; Screening; Contrast Enhanced Mammography

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Inadequate surgical margins rate in the Interventional Group

  Percentage of patients with inadequate surgical margins (\<2mm)

  3 years

• Inadequate surgical margins rate in the Control Group

  Percentage of patients with inadequate surgical margins (\<2mm)

  3 years

• Re-operation rate in the Interventional Group

  Percentage of repeated surgical procedures in breast

  3 years

• Re-operation rate in the Control Group

  Percentage of repeated surgical procedures in breast

  3 years

• Mastectomy rate in the Interventional Group

  Percentage of patients with mastectomy

  3 years

• Mastectomy rate in the Control Group

  Percentage of patients with mastectomy

  3 years

Secondary Outcomes (18)

• Estimated percentage of breast resection volume based on CEM

  3 years

• Estimated percentage of breast resection volume based on MMG

  3 years

• Duration of complete preoperative diagnostic workup in the Intervention Group

  3 years

• Duration of complete preoperative diagnostic workup in the Control Group

  3 years

• Lesion extension of high-grade DCIS (G3) on CEM

  3 years

Study Arms (2)

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.

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.

Interventions

Contrast Enhanced Mammography DIAGNOSTIC_TEST

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.

Also known as: CEM

Interventional Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Clinical Hospital Centre Rijeka

Rijeka, Primorsko Goranska County, 51000, Croatia

Location

Related Publications (5)

• 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.

  PMID: 29064748 BACKGROUND

• 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.

  PMID: 33222993 BACKGROUND

• 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.

  PMID: 28445683 BACKGROUND

• 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.

  PMID: 34643778 BACKGROUND

• 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/diagnostics13111958.

  PMID: 37296810 RESULT

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Calcinosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Petra Valkovic Zujic, PhD

CONTACT

+98598713493; petra.valkovic@gmail.com

Ana Car Peterko

CONTACT

+385989798103; anacarpeterko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Abdominal and Breast Division Department of Radiology

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 22, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)