Biopsy of Calcifications Under Contrast Enhancement Guide (BoCCE)

NAActive, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 24, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2025

Conditions
Breast CancerCalcification
Interventions
OTHER

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).

OTHER

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)."

Trial Locations (1)

42123

Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia

All Listed Sponsors
collaborator

General Electric

INDUSTRY

lead

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV