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Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer

RecruitingNAAges 18 Years - 75 YearsFemaleAll India Institute of Medical Sciences, Bhubanes…
NCT07478900 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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),

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📋 Eligibility rules (as published)
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
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What it tests

  • Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study
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Where

1 site
AIIMS Bhubaneswar
Bhubaneswar, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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