Evaluating Phase Contrast Mammography for Breast Cancer Detection Compared to Standard Mammography in Adults

What this Trial Is About

Researchers are evaluating the imaging quality and clinical relevance of phase contrast mammography PCM in detecting breast cancer, especially in patients with dense breast tissue where conventional mammography sensitivity is limited. This observational study includes multiple phases to validate image quality and radiation dose, and to compare PCM with conventional digital mammography and ultrasound. The study is sponsored by the University of Zurich and aims to improve breast cancer detection methods. The study has three phases. Phase 0 involves imaging mastectomy and biopsy samples after surgery to validate image quality and radiation dose. Phase 1 assesses accurate in vivo radiation dose and evaluates cohort size, performing PCM before surgery for known breast cancer cases. Phase 2 compares the diagnostic performance of PCM with conventional digital mammography during routine clinical use, involving up to 300 participants undergoing mammography for screening or diagnosis. Participants will undergo PCM and conventional imaging tests, including mammography and ultrasound, with results compared for sensitivity and specificity. Breast tissue samples from surgery serve as a reference for lesion extent. The study tracks radiation doses and diagnostic accuracy over 30 months. Safety is monitored by excluding pregnant or breastfeeding women and those with recent radiation exposure. Participant involvement includes imaging procedures and consent to data collection throughout the study.

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