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Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study

Recruitingn/aAges 18 Years - anyAllUniversity of Zurich
NCT06489665 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Inclusion criteria -Phase 0: * \>18 years * Mastectomy, tumorectomy or biopsy planned * Informed consent of the patient Inclusion criteria -Phase 1: * \>18 years * BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy); * Scheduled for mastectomy or breast conserving surgery with radiotherapy. * Informed consent of the patient Inclusion criteria - Phase 2: * \>40 years * undergoing mammography for screening or diagnostic purpose. * Informed consent of the patient Exclusion Criteria: * Exclusion criteria for all three Phases: * Breast implants. The women will be asked, if they have a breast-implant. * Inability to understand the study procedure due to cognitive or linguistic deficits. Exclusion criteria for patients, participating in Phase 1 and Phase 2: * Pregnancy * Breast-feeding. * Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
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What it tests

  • Experimental Intervention
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Where

2 sites
University Hospital Zurich - Diagnostic Radiology
Zurich, Switzerland
University of Zurich
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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