NCT06489665 Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
| NCT ID | NCT06489665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2024-10-17 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.
Eligibility 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
Contact & Investigator
Thomas Frau, Prof
PRINCIPAL INVESTIGATOR
University Hospital Zurich, DIR
Frequently Asked Questions
Who can join the NCT06489665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06489665 currently recruiting?
Yes, NCT06489665 is actively recruiting participants. Contact the research team at thomas.frauenfelder@usz.ch for enrollment information.
Where is the NCT06489665 trial being conducted?
This trial is being conducted at Zurich, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT06489665 clinical trial?
NCT06489665 is sponsored by University of Zurich. The principal investigator is Thomas Frau, Prof at University Hospital Zurich, DIR. The trial plans to enroll 350 participants.
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