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

NCT07478900 | Recruiting

• 1 other identifier: IEC/AIIMSBBSR/PG/2025-26/53
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer (Locally Advanced or Metastatic); Tattoo Skin Markers; Neoadjuvant Chemoimmunotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

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.

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

Interventions

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

tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS Bhubaneswar

Bhubaneswar, Odisha, 751019, India

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mithilesh K Sinha, MS

CONTACT

+919438884252; surg_mithilesh@aiimsbhubaneswar.edu.in

Banothu Raju, MBBS

CONTACT

+917993575975; banothu905@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 18, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 9, 2027
• Study Completion (Estimated): February 9, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IN (1)