The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent … (NCT06217458) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS
Croatia100 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of true positive CEMs in the Interventional group
Timeframe: 3 years
2
Number of false positive CEMs in the Interventional Group
Timeframe: 3 years
3
Number of true negative CEMs in the Interventional Group
Timeframe: 3 years
4
Number of false negative CEMs in the Interventional Group
Timeframe: 3 years
5
True positive rate of CEM vs. MMG (Sensitivity)
Timeframe: 3 years
6
True negative rate of CEM vs. MMG (Specificity)
Timeframe: 3 years
7
False positive rate of CEM vs. MMG (overestimation)
Timeframe: 3 years
8
False negative rate of CEM vs. MMG (underestimation)