NCT06489665Recruiting
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Summary
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.
Eligibility criteria
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland
- Sponsor
- University of Zurich(Other)
- Protocol no.
- 2021-00200
- Conditions
- Breast Cancer, Microcalcification, Image
- Interventions
- Diagnostic test
Treatments studied
- Experimental Intervention
Collaborators
Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland, GratXray AG
Locations · 2
- Zurich, SwitzerlandUniversity Hospital Zurich - Diagnostic RadiologyRecruiting at this site
- Zurich, SwitzerlandUniversity of ZurichRecruiting at this site
In total, worldwide, both sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: February 5, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.