Evaluating a new imaging technique for breast cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of phase contrast mammography in detecting breast cancer, particularly in patients with dense breast tissue. It involves three phases: imaging of surgical samples to validate quality, determining radiation doses in living patients, and comparing the diagnostic performance of phase contrast mammography with conventional methods. The study will include a total of approximately 350 participants across different phases, focusing on sensitivity and specificity outcomes.

Why it matters

Who can join: the full rules

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's running

• University Hospital Zurich - Diagnostic Radiology
  Zurich, Canton of Zurich, Switzerland Recruiting
• University of Zurich
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Thomas Frau, Prof — University Hospital Zurich, DIR
• Study coordinator: Thomas Frauenfelder, Prof
• Email: thomas.frauenfelder@usz.ch
• Phone: +41 44 255 93 83

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.