Recruiting
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
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.
ClinicalTrials.gov IDNCT06489665
PhaseNot Applicable
Enrollment350
SponsorUniversity of Zurich
Age18 Years
SexALL
Conditions studied
Breast Cancer, Microcalcification, Image
About this study
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.
Interventions
- Diagnostic Test: Experimental Intervention — Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device
Primary outcomes
- Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM. (30 month)
Eligibility information
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
Study locations
- University Hospital Zurich - Diagnostic Radiology, Zurich, Canton of Zurich 8091 Switzerland
- University of Zurich, Zurich, Switzerland
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.