Status:
NOT_YET_RECRUITING
The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS
Lead Sponsor:
Clinical Hospital Center Rijeka
Conditions:
DCIS
Breast Carcinoma in Situ
Eligibility:
FEMALE
18-99 years
Phase:
NA
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 pat...
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06217458
Start Date
March 1 2025
End Date
January 1 2027
Last Update
January 6 2025
Active Locations (1)
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1
Clinical Hospital Centre Rijeka
Rijeka, Primorsko Goranska County, Croatia, 51000