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

Официальное название

Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Complete excision of breast tumor with negative histopathological margins (R0 Resection) [Срок оценки: Tumor margins will be assessed intraoperatively by frozen section biopsy and subsequently confirmed by the final histopathological examination two weeks after the procedure.]
• Complete Pathological Excision of the Breast Tumor (R0 Resection) [Срок оценки: The study will be conducted over 24 months (November 2025-October 2027). Patients will be followed for wound-related complications for two weeks, with additional follow-up at one and three months to assess wound healing and patient satisfaction.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Индия · 1 центр

• AIIMS Bhubaneswar — Bhubaneswar

Идентификаторы

NCT: NCT07478900 · IEC/AIIMSBBSR/PG/2025-26/53 · IEC/AIIMSBBSR/PG/2025-26/53

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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