Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Recruiting · NCT06489665 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Zurich
View the official record on ClinicalTrials.gov →Interventions studied
Experimental Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- University of Zurich - Zurich, Switzerland
- University Hospital Zurich - Diagnostic Radiology - Zurich, Canton of Zurich, Switzerland