Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete excision of breast tumor with negative histopathological margins (R0 Resection)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer
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.
干预措施: Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study (Procedure)
结局指标
主要结局
Complete excision of breast tumor with negative histopathological margins (R0 Resection)
时间窗: 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)
时间窗: 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.
The study will be conducted over 24 months (November 2025-October 2027) in the Department of General Surgery. Eligible patients undergoing Breast-Conserving Surgery for Breast Cancer will be enrolled. Excised specimens will undergo Histopathological Examination to assess surgical margins. The primary outcome is the achievement of negative margins. If negative margins are obtained, the surgery will be considered successful; positive margins will require revision surgery (re-excision) and will be recorded as failure of the primary procedure. 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. Data collection will occur within the study period. Data analysis and manuscript preparation will done thereafter.
次要结局
未报告次要终点
研究者
Mithilesh Kumar sinha
Professor
All India Institute of Medical Sciences, Bhubaneswar