Clinical trial · Interventional
Biopsy of Calcifications Under Contrast Enhancement Guide (BoCCE)
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Calcification | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast enhanced mammography guided biopsy (diagnostic procedure) | Other | — | UNRESOLVED |
| Mammography guided biopsy (diagnostic procedure) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Contrast enhanced mammography guided biopsy
- description
- Patients will be subjected to CESM; the two orthogonal mammographic projections, after intravenous administration of iodized contrast-enhancement (Omnipaque), will be performed. Surgical and medical treatments will be defined accordingly to the imaging and histological findings obtained with the experimental procedure.
- interventionNames
- Other: Contrast enhanced mammography guided biopsy (diagnostic procedure)
- type
- ACTIVE_COMPARATOR
- label
- mammography guided biopsy
- description
- Patients will be subjected to stereotactic biopsy Mammotome as normal clinical practice. Surgical and medical treatments will be defined accordingly to the imaging and histological findings obtained with the standard procedure.
- interventionNames
- Other: Mammography guided biopsy (diagnostic procedure)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Women with contraindication to the administration of iodized contrast medium will be excluded.
References
Publications (6)
- BACKGROUNDNarayan AK, Keating DM, Morris EA, Mango VL. Calling all calcifications: a retrospective case control study. Clin Imaging. 2019 Jan-Feb;53:151-154. doi: 10.1016/j.clinimag.2018.09.016. Epub 2018 Oct 5. PMID 30340079
- BACKGROUNDSi J, Guo R, Huang N, Xiu B, Zhang Q, Chi W, Wu J. Axillary evaluation is not warranted in patients preoperatively diagnosed with ductal carcinoma in situ by core needle biopsy. Cancer Med. 2019 Dec;8(18):7586-7593. doi: 10.1002/cam4.2623. Epub 2019 Oct 29. PMID 31660702
- BACKGROUNDJakub JW, Murphy BL, Gonzalez AB, Conners AL, Henrichsen TL, Maimone S 4th, Keeney MG, McLaughlin SA, Pockaj BA, Chen B, Musonza T, Harmsen WS, Boughey JC, Hieken TJ, Habermann EB, Shah HN, Degnim AC. A Validated Nomogram to Predict Upstaging of Ductal Carcinoma in Situ to Invasive Disease. Ann Surg Oncol. 2017 Oct;24(10):2915-2924. doi: 10.1245/s10434-017-5927-y. Epub 2017 Aug 1. PMID 28766196
- BACKGROUNDGrimm LJ, Ryser MD, Partridge AH, Thompson AM, Thomas JS, Wesseling J, Hwang ES. Surgical Upstaging Rates for Vacuum Assisted Biopsy Proven DCIS: Implications for Active Surveillance Trials. Ann Surg Oncol. 2017 Nov;24(12):3534-3540. doi: 10.1245/s10434-017-6018-9. Epub 2017 Aug 9. PMID 28795370
- BACKGROUNDCheung YC, Tsai HP, Lo YF, Ueng SH, Huang PC, Chen SC. Clinical utility of dual-energy contrast-enhanced spectral mammography for breast microcalcifications without associated mass: a preliminary analysis. Eur Radiol. 2016 Apr;26(4):1082-9. doi: 10.1007/s00330-015-3904-z. Epub 2015 Jul 10. PMID 26159872
- BACKGROUNDIotti V, Ragazzi M, Besutti G, Marchesi V, Ravaioli S, Falco G, Coiro S, Bisagni A, Gasparini E, Giorgi Rossi P, Vacondio R, Pattacini P. Accuracy and Reproducibility of Contrast-Enhanced Mammography in the Assessment of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients with Calcifications in the Tumor Bed. Diagnostics (Basel). 2021 Mar 4;11(3):435. doi: 10.3390/diagnostics11030435.