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
All India Institute of Medical Sciences, Bhubaneswar
30 participants
Sep 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Eligible patients with biopsy-proven breast cancer and axillary lymph node metastasis presenting with clinical T1-T2 disease will undergo localization of the primary tumor prior to initiation of neoadjuvant chemotherapy. The procedure will be performed with the patient in the supine position and the ipsilateral arm abducted to 90°, simulating the surgical position. Clinically palpable tumor margins will be identified and marked on the overlying skin using sterile permanent tattoo ink to delineate the pretreatment tumor boundaries. In patients with deep, poorly palpable, or mobile tumors, additional localization will be achieved by placement of radiopaque clips within the tumor under ultrasonographic guidance. Following localization, patients will receive standard neoadjuvant chemotherapy according to institutional protocols. Treatment response will be monitored clinically and radiologically, and the tattoo markings and/or clips will guide surgical planning for breast-conserving surgery
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07478900