Status:
NOT_YET_RECRUITING
IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors
Lead Sponsor:
Istituto Oncologico Veneto IRCCS
Conditions:
Breast Cancer
Breast-Conserving Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions. Participant eligible for the study will be randomized in a 1:1:1 ra...
Detailed Description
Breast-conserving surgery is the gold standard treatment for early breast cancer, since it has shown disease-free survival rates equivalent to those of mastectomy, offering the advantages of cosmetic ...
Eligibility Criteria
Inclusion
- Patients with non-palpable breast cancer candidate for breast-conserving surgery;
- Female patients;
- Patients aged ≥ 18 years;
- Patients with histologic diagnosis of cT1-T2 invasive BC or ductal carcinoma in situ;
- Patients amenable for BCS after neoadjuvant chemotherapy;
- Patients who are able to give informed consent.
Exclusion
- Pregnancy or lactation;
- Patients with locally advanced disease or metastatic disease;
- Patients with palpable breast carcinoma;
- Patients candidate for mastectomy;
- Patients who are unable to give informed consent
- Patients candidate for mastectomy.
Key Trial Info
Start Date :
January 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1302 Patients enrolled
Trial Details
Trial ID
NCT07185568
Start Date
January 31 2026
End Date
December 31 2027
Last Update
December 16 2025
Active Locations (5)
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1
Azienda Ospedaliera San Giovanni Addolorata
Roma, RM, Italy
2
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
3
AOU Policlinico di Modena
Modena, Italy
4
ASL2 Abruzzo, Ospedale "Gaetano Bernabeo", Ortona
Ortona, Italy