Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study

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Objective(s):

Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. Evaluation of cohort size for phase 2. Phase 2: Assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography.

Ouctomes: Sensitivity and specificity of phase contrast mammography compared to conventional digital mammography.

Measurements and procedures:

Phase 0: Phase contrast mammography of the mastectomy, tumorectomy or breast biopsy samples is performed after breast surgery in addition to the standard clinical procedures Phase 1: Phase contrast mammography is performed before the operation in case of known breast carcinoma in addition to the standard clinical procedures Phase 2: Phase contrast mammography is performed directly in the clinical routine. The result is compared with the result of the conventional digital mammography and the ultrasound examination.

Number of Participants with Rationale:

Phase 0: expected to be 30 Phase 1: expected to be 20 Phase 2: expected to be 300 (correct number will be defined according to Phase 1)

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