RecruitingNCT06489665
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Imaging Quality and Potential Clinical Relevance of Phase Contrast
Sponsor
University of Zurich
Enrollment
350 participants
Start Date
Oct 17, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria10
- \>18 years
- Mastectomy, tumorectomy or biopsy planned
- Informed consent of the patient
- \>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
- \>40 years
- undergoing mammography for screening or diagnostic purpose.
- Informed consent of the patient
Exclusion Criteria5
- 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.
- Pregnancy
- Breast-feeding.
- Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
Interventions
DIAGNOSTIC_TESTExperimental Intervention
Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06489665
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