The diagnostic performance of phase contrast mammography compared to full-field digital mammography.
Résumé de l'étude
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 étudiée
Phase contrast mammography compared to full-field digital mammography.
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Institut für Interventionelle und diagnostische Radiologie USZ
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Thomas Frauenfelder
Tel.: +41 – 44 2559383
thomas.frauenfelder@clutterusz.chUniversitätsSpital Zürich Diagnostische und Interventionelle Radiologie
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
23.03.2021
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Imaging quality and potential clinical relevance of phase contrast mammography in-vivo: a singlecenter, prospective study (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible