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Search / Trial NCT06217458

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

Launched by CLINICAL HOSPITAL CENTER RIJEKA · Jan 19, 2024

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

Ductal In Situ Carcinoma Calcifications Breast Surgery Screening Contrast Enhanced Mammography

ClinConnect Summary

This clinical trial is studying whether adding a special type of imaging called Contrast Enhanced Mammography (CEM) to standard mammography can help doctors better understand how much ductal carcinoma in situ (DCIS) is present in patients' breasts before surgery. The goal is to see if using CEM alongside standard imaging can result in fewer patients needing further surgery, like a re-excision or mastectomy, because they had clearer information about their cancer.

To be eligible for this trial, participants must be women aged 36 to 74 who have a confirmed diagnosis of DCIS from a recent breast biopsy. They should be scheduled for surgery at a specific hospital in Croatia and agree to join the study. However, certain individuals, such as those with kidney problems, allergies to the contrast dye, or those who have had previous breast surgery for invasive cancer, cannot participate. If you take part in this study, you can expect to undergo both standard mammography and CEM before your surgery, helping your doctors make more informed decisions about your treatment.

Gender

FEMALE

Eligibility criteria

  • 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

About Clinical Hospital Center Rijeka

The Clinical Hospital Center Rijeka is a leading medical institution in Croatia, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence in patient care, the center integrates multidisciplinary expertise and state-of-the-art facilities to facilitate high-quality clinical research. It aims to enhance medical knowledge and therapeutic options by conducting rigorous trials across various specialties, ensuring the safety and well-being of participants while contributing to the global medical community.

Locations

Rijeka, Primorsko Goranska County, Croatia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported