Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer
Recruiting · NCT07478900 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- AIIMS Bhubaneswar - Bhubaneswar, Odisha, India