Clinical trial · Interventional
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study
- 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)
Study Description This prospective cohort study evaluates the feasibility and effectiveness of pre-neoadjuvant tumor localization using skin tattooing, with or without radiopaque clips, in patients with biopsy-proven T2-T3 breast cancer and axillary lymph node metastasis. Eligible patients will undergo tumor localization in the supine position with the ipsilateral arm abducted to 90°. Palpable tumor margins will be marked with sterile tattoo ink, and deep or mobile tumors will receive additional localization with ultrasonography-guided radiopaque clips. Following localization, patients will receive standard neoadjuvant chemotherapy. Tumor response will be monitored clinically and radiologically. Post-therapy, the tattoo markings and/or clips will guide breast-conserving surgery. Primary outcomes include feasibility of breast conservation, achievement of negative margins (R0 resection), and avoidance of mastectomy, while intraoperative technical challenges will also be documented.
Conditions
Conditions (3)
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 (Locally Advanced or Metastatic) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Neoadjuvant Chemoimmunotherapy | — | UNRESOLVED | — |
| Tattoo Skin Markers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer
- description
- Patients with breast cancer and axillary lymph node metastasis presenting with T1 or T2 stage disease will undergo localization of the primary tumor site using skin tattooing performed in the supine position with the arms abducted at a right angle. In cases of deep-seated or highly mobile tumors, additional localization will be achieved by placement of radiopaque clips under ultrasonographic guidance. Following tumor localization, patients will receive neoadjuvant chemotherapy, and treatment response will be systematically monitored. The feasibility of breast-conserving surgery in this cohort will be evaluated, and any technical challenges encountered during the procedure will be documented. The primary outcome measures will include achievement of negative surgical margins and avoidance of mastectomy.
- interventionNames
- Procedure: Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study
Primary outcomes (2)
- measure
- Complete excision of breast tumor with negative histopathological margins (R0 Resection)
- timeFrame
- Tumor margins will be assessed intraoperatively by frozen section biopsy and subsequently confirmed by the final histopathological examination two weeks after the procedure.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Female patients aged 18-75 years Histologically confirmed Breast Cancer on biopsy Patients with T2 or T3 breast tumors planned for Neoadjuvant Chemotherapy Presence of a clinically palpable primary breast tumor suitable for localization Patients who are candidates for Breast-Conserving Surgery following neoadjuvant therapy Ability and willingness to provide written informed consent Exclusion Criteria: Known allergy or hypersensitivity to tattooing materials used for tumor localization Early-stage Breast Cancer not requiring Neoadjuvant Chemotherapy Diagnosis of Inflammatory Breast Cancer T3 tumors in patients with small breast size or T4 breast cancer Patients unwilling to undergo Breast-Conserving Surgery Diffuse microcalcifications of the breast parenchyma on Mammography Ductal Carcinoma In Situ Male Breast Cancer Multicentric or multifocal breast cancers Tumor location that precludes breast-conserving surgery Recurrent Breast Cancer
References
Publications (0)
Data not yet available