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Biopsy of Calcifications Under Contrast Enhancement Guide (BoCCE)
Sponsor: Azienda USL Reggio Emilia - IRCCS
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 need histological assessment with stereotaxic guided biopsy (Mammotome). With extended calcifications, choosing the best area to biopsy may be challenging. The main objective of this 1:1 randomized controlled clinical trial is to compare the accuracy of the CESM guide (study arm with biopsy under CESM guidance) with the traditional Mammotome (control arm with biopsy under stereotactic guidance) in conducting the biopsy in the area of greatest malignancy/grade of the lesion, using as gold-standard the histological exam of the operating piece. Women recalled with indication to perform stereotactic biopsy for clusters of suspicious calcifications on mammography (BIRADS R3 or R4 or R5) not mass-associated will be included. Anticipated sample size is 100 women per arm.
Official title: Studio BoCCE: Ruolo Della Biopsia Sotto Guida CEM (Mammografia Con Mezzo di Contrasto) Nella Caratterizzazione Delle Calcificazioni Dubbie o Sospette (BIRADS R3, R4, R5) Non Associate a Masse.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-07-24
Completion Date
2025-12-31
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (1)
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy