Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IEC/AIIMSBBSR/PG/2025-26/53 | Other Identifier | AIIMS Bhubaneswar |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete excision of breast tumor with negative histopathological margins (R0 Resection) | 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) | 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. | 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. |
Not provided
Not provided
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
Eligible participants are biologically female individuals diagnosed with breast cancer and axillary lymph node metastasis. Inclusion is limited to those with female breast tissue suitable for tumor localization, neoadjuvant chemotherapy, and breast-conserving surgery. Gender identity is not a criterion for exclusion, but participants must have the anatomical structures relevant to the intervention and surgical procedures under study. Male breast cancer cases are excluded due to differences in tumor presentation, anatomy, and surgical considerations.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mithilesh K Sinha, MS | Contact | +919438884252 | surg_mithilesh@aiimsbhubaneswar.edu.in | |
| Banothu Raju, MBBS | Contact | +917993575975 | banothu905@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIIMS Bhubaneswar | Recruiting | Bhubaneswar | Odisha | 751019 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided