Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Recruiting
Observational Study
Breast CancerMicrocalcificationImage
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
350 (estimated)
Sponsor
University of Zurich · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 malig…
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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