The diagnostic performance of phase contrast mammography compared to full-field digital mammography.
Summary description of the study
Both full-field digital mammography (X-ray), breast ultrasound (radio waves), and breast MRI have specific weaknesses. Mammography has a low sensitivity for detecting breast cancer in patients with dense breasts. Phase contrast mammography is a new development in the field of breast imaging, based on capturing phase contrast and dark field imaging. Compared to full-field digital mammography, which relies solely on the contrast of X-ray attenuation, phase contrast and dark field imaging utilizes the contrast of electron density and the scattering ability of the tissue. This is the world's first phase contrast mammography device. Preliminary studies examining samples from mastectomy showed higher image quality and improved representation of lesions. With this study, we aim to assess the diagnostic performance of phase contrast mammography compared to full-field digital mammography.
(BASEC)
Intervention under investigation
Phase contrast mammography compared to full-field digital mammography.
(BASEC)
Disease under investigation
Breast cancer
(BASEC)
o Phase 0: Mastectomy and tissue samples from breast biopsies o Phase 1: Women with breast cancer and planned mastectomy or conservative surgery + radiotherapy o Phase 2: Women scheduled for a diagnostic or screening mammography Additionally, they must be over 18 years old (40 years for Phase 2). Women who are pregnant, breastfeeding, undergoing neoadjuvant chemotherapy, or have breast implants are not allowed to participate. (BASEC)
Exclusion criteria
Women who are pregnant, breastfeeding, undergoing neoadjuvant chemotherapy, or have breast implants, who cannot understand the procedure and who have already participated in a project involving radiation in the last 12 months. (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Institut für Interventionelle und diagnostische Radiologie USZ
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Thomas Frauenfelder
Tel.: +41 – 44 2559383
thomas.frauenfelder@clutterusz.chUniversitätsSpital Zürich Diagnostische und Interventionelle Radiologie
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
23.03.2021
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Imaging quality and potential clinical relevance of phase contrast mammography in-vivo: a singlecenter, prospective study (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
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Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available