Evaluating a new imaging technique for breast cancer detection
Imaging Quality and Potential Clinical Relevance of Phase Contrast
University of Zurich · NCT06489665
This study is testing a new type of mammogram called phase contrast mammography to see if it can better detect breast cancer in women with dense breast tissue compared to regular methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Zurich, Canton of Zurich and 1 other locations) |
| Trial ID | NCT06489665 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women over 40 undergoing routine mammography or those scheduled for breast surgery due to suspected malignancy.
Not a fit: Patients with breast implants or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly improve breast cancer detection rates, especially in women with dense breast tissue.
How similar studies have performed: While phase contrast mammography is a novel approach, similar imaging techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Zurich, Canton of Zurich and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Microcalcification, Image, Mammography