200
Participants
Start Date
July 24, 2021
Primary Completion Date
December 31, 2023
Study Completion Date
December 31, 2025
Contrast enhanced mammography guided biopsy (diagnostic procedure)
With visible contrast-enhancement, stereotactic biopsy will be performed under CESM guidance. After administration of an additional dose of iodized contrast-enhancement (Omnipaque), the insertion of the biopsy needle and the biopsy sampling will be targeted on the area of greatest enhancement in the context of calcifications. In the absence of contrast-enhancement, stereotactic biopsy Mammotome will be performed, using X-ray guidance. The insertion of the biopsy needle and biopsy will be targeted on the most suspicious calcification cluster or area. At the end of the procedure, a metal clip marker will be placed in the biopsy site; the placement will be verified with dual orthogonal mammography projection (as regular clinical practice).
Mammography guided biopsy (diagnostic procedure)
"For all lesions, stereotactic biopsy Mammotome will be performed, using X-ray guidance. The insertion of the biopsy needle and biopsy will be targeted on the most suspicious calcification cluster or area.~At the end of the procedure, a metal clip marker will be placed in the biopsy site; the placement will be verified with dual orthogonal mammography projection (as regular clinical practice)."
Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia
General Electric
INDUSTRY
Azienda USL Reggio Emilia - IRCCS
OTHER_GOV