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NCT04862429: BoCCE
Biopsy of Calcifications Under Contrast Enhancement Guide (BoCCE)
NA trial testing Contrast enhanced mammography guided biopsy (diagnostic procedure) in Breast Cancer in 200 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2023
Quick facts
| Lead sponsor | Azienda USL Reggio Emilia - IRCCS |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 200 |
| Start date | 24 July 2021 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Contrast enhanced mammography guided biopsy (diagnostic procedure)
- Mammography guided biopsy (diagnostic procedure)
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Calcification — all drugs for Calcification →
Sponsor
Azienda USL Reggio Emilia - IRCCS — full company profile →
Who can join
18 and older, female only, with Breast Cancer or Calcification. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04862429
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Azienda USL Reggio Emilia - IRCCS trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04862429 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda USL Reggio Emilia - IRCCS
- Last refreshed: 25 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04862429.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing