Status:
ACTIVE_NOT_RECRUITING
Biopsy of Calcifications Under Contrast Enhancement Guide (BoCCE)
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Collaborating Sponsors:
General Electric
Conditions:
Breast Cancer
Calcification
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Calcification clusters are 30-40% of recalls in mammographic screening, but have a low positive predictive value (\~15%) for ductal cancer in situ (DCIS) or invasive cancer. These calcifications often...
Detailed Description
Rationale Suspicious calcifications requiring further assessment are about 30-40% of recalls in mammographic screening. Nevertheless these findings have low positive predictive value (\~15%) for ducta...
Eligibility Criteria
Inclusion
- Women with clinical mammography and screening recalls with mammographic confirmation of clusters of suspicious calcifications (BIRADS R3 or R4 or R5) not mass-associated will be included, with indication to perform stereotactic biopsy, evaluated at the Breast Care Facility of AUSL-IRCCS in Reggio Emilia.
Exclusion
- Women with contraindication to the administration of iodized contrast medium will be excluded.
Key Trial Info
Start Date :
July 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04862429
Start Date
July 24 2021
End Date
December 31 2025
Last Update
June 25 2025
Active Locations (1)
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1
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy, 42123