Status:
RECRUITING
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland
GratXray AG
Conditions:
Breast Cancer
Microcalcification
Eligibility:
All Genders
18+ years
Brief Summary
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 br...
Detailed Description
Category C2 Medicine product without CE label. Objective(s): Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06489665
Start Date
October 17 2024
End Date
September 1 2030
Last Update
February 5 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Zurich - Diagnostic Radiology
Zurich, Canton of Zurich, Switzerland, 8091
2
University of Zurich
Zurich, Switzerland