Prospective, randomized, controlled, multicenter, operative study to evaluate the role of intraoperative sonography compared to the preoperative wire localization in the treatment of non-palpable breast cancer

Prospective, randomized, controlled, multicenter, operative study to evaluate the role of intraoperative sonography compared to the preoperative wire localization in the treatment of non-palpable breast cancer - US-WIRE-Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010174

Enrollment

230

Registered

2016-03-11

Start date

2017-04-11

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: Control group: BEI (breast-conserving surgery) after preoperative ultrasound-guided wire localization Before the operation, the wire marking is done. The wire marking is performed under mamm

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - written consent after verbal clarification by an Study physician for this study is available - Histologically proven invasive breast cancer - Non-palpable tumor - Indication for BEI - CT1b-cT2 - Female patient> 18 years - Sonographically detectable tumor in two levels - Karnofsky Performance Status - Index =70% or ECOG <2

Exclusion criteria

Exclusion criteria: - Multifocal tumor - Recurrence of breast cancer - Tumor <5mm - Inability to understand the meaning and purpose of the clinical trial or the comply with conditions for studying OP capability not available

Design outcomes

Primary

Measure	Time frame
Comparison of R0 resections, ie the rate of histologically safe in healthy distant breast cancer, with a safety margin of 1mm, at BEI after wire localization vs. BEI after intraoperative US, with the objective of demonstrating non-inferiority of the intraoperative ultrasound with respect to the wire marking.	—

Secondary

Measure	Time frame
Secondary study objectives: - Comparison of the rate of intraoperative resections under two localization methods - Comparison of the rate of second operations under both localization methods - Comparison of the remote resection volume in both arms - Cosmetic Results - Operation time - Determining an optimum ultrasound distance between the tumor and the resection margin in order to achieve a minimal histological safety margin of 1mm - Evaluation of the measured tumor size in breast ultrasound, mammography and possibly in MR mammography compared to pathologically measured tumor size - Determination of characteristics of tumor biology, which are associated with an extensive intraductal component.	—

Measure

Time frame

Secondary study objectives: - Comparison of the rate of intraoperative resections under two localization methods - Comparison of the rate of second operations under both localization methods - Comparison of the remote resection volume in both arms - Cosmetic Results - Operation time - Determining an optimum ultrasound distance between the tumor and the resection margin in order to achieve a minimal histological safety margin of 1mm - Evaluation of the measured tumor size in breast ultrasound, mammography and possibly in MR mammography compared to pathologically measured tumor size - Determination of characteristics of tumor biology, which are associated with an extensive intraductal component.

—

Countries

Germany

Contacts

Public ContactSabrina Rudolph

Universitätsfrauenklinik

sabrina.rudolph@med.ovgu.de+49-391-67-17473

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026