Clinical trial · Interventional
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: a Prospective Randomized Control Trial.
NCT05797454CI-TRIAL-00078505unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
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 |
| Breast-conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wire-guided localization | Procedure | — | UNRESOLVED |
| Wire-guided localization and marker clip localization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Untreated patients-combined localization
- description
- In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation
- interventionNames
- Procedure: Wire-guided localization and marker clip localization
- type
- ACTIVE_COMPARATOR
- label
- Untreated patients-single localization
- description
- In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation
- interventionNames
- Procedure: Wire-guided localization
Primary outcomes (1)
- measure
- positive margin rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. female patients, age≥18 year 2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale 3. Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization 4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery. Exclusion criteria: 1. Inflammatory breast cancer or Paget's disease 2. Breast deformities and other conditions that impact breast conservation success rate 3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded 4. Pregnancy or lactation 5. Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment 6. Patients with stage IV diseases or unresectable lesions in either breast 7. Patients combined with other diseases that may affect survival 8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations 9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.