Methods for locating different types of breast lesions
Official title: A Prospective Non-interventional Multicenter Cohort Study to Evaluate Different Imaging-guided Methods for Localization of Non-palpable Malignant Breast Lesions
Run by European Breast Cancer Research Association of Surgical Trialists · NCT05559411 · Data updated 2026-11-12
This study is testing different ways to find hard-to-detect breast tumors in patients needing surgery to see if these methods can help doctors remove the tumors more accurately and reduce the chances of needing more surgery later.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 7416 (estimated) |
| Sponsor | European Breast Cancer Research Association of Surgical Trialists Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lübeck) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT05559411 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with malignant breast lesions requiring breast-conserving surgery and imaging-guided localization.
✕Probably not a fit
Patients who are not suitable for surgical treatment or those requiring mastectomy as their first surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on improving the localization techniques for non-palpable breast lesions in patients requiring breast-conserving surgery. It aims to evaluate various imaging-guided methods, such as wire-guided localization and intraoperative ultrasound, to enhance the accuracy of tumor removal and minimize the need for re-operations. By analyzing the effectiveness of these techniques, the study seeks to reduce local recurrence rates and improve patient outcomes. The study includes both male and female patients aged 18 and older with malignant breast lesions.
Why it matters
Potential benefit: If successful, this study could lead to more effective surgical techniques that reduce the need for additional surgeries and improve overall patient outcomes.
How similar studies have gone: Other studies have shown success with similar imaging-guided localization techniques, indicating potential for effective outcomes in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent form * Malignant breast lesion requiring breast-conserving surgery and imaging-guided localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and the use of neoadjuvant chemotherapy are allowed) * Planned surgical removal of the lesion using one or more of the following imaging-guided localization techniques: * Wire-guided localization * Intraoperative ultrasound * Magnetic localization * Radioactive seed localization * Radioguided Occult Lesion Localization (ROLL) * Radar localization * Radiofrequency identification (RFID) tag localization * Ink/carbon localization * Female / male patients ≥ 18 years old Exclusion Criteria: * Patients not suitable for surgical treatment * Patients requiring mastectomy as first surgery * Surgical removal without imaging-guided localization
Where it's running
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University Hospital Schleswig-Holstein Campus Lübeck
Lübeck, Germany Recruiting
Study contacts
- Study coordinator: Maggie Banys-Paluchowski, Priv.-Doz. Dr. med.
- Email: Maggie.Banys-Paluchowski@uksh.de
- Phone: +494515000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.