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NOT YET RECRUITING
NCT06217458
NA

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

Sponsor: Clinical Hospital Center Rijeka

View on ClinicalTrials.gov

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.

Official title: The Added Value of Contrast Enhanced Mammography (CEM) to Standard Mammography in Assessing the Extent of Ductal Carcinoma in Situ (DCIS)

Key Details

Gender

FEMALE

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-03-01

Completion Date

2027-01-01

Last Updated

2025-01-06

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Contrast Enhanced Mammography

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.

Locations (1)

Clinical Hospital Centre Rijeka

Rijeka, Primorsko Goranska County, Croatia