Skin tattoo marks (and optional clips) to guide breast-conserving surgery before chemotherapy
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study
This study will test whether marking palpable tumor edges with sterile skin tattoos, with or without small radiopaque clips, before neoadjuvant chemotherapy helps surgeons perform breast-conserving surgery in adults with T2–T3 breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT07478900 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study enrolls patients with biopsy-proven T2–T3 palpable breast tumors, places sterile tattoo ink marks around tumor margins with the patient supine and the ipsilateral arm abducted to 90°, and adds ultrasound-guided radiopaque clips for deep or mobile lesions. Patients then receive standard neoadjuvant chemotherapy while tumor response is followed clinically and with imaging. After systemic therapy, the skin tattoos and/or clips are used to guide breast-conserving surgery and intraoperative challenges are recorded. Primary outcomes include rate of successful breast conservation, achievement of negative (R0) margins, and avoidance of mastectomy.
Who should consider this trial
Good fit: Adult women aged 18–75 with biopsy-confirmed T2–T3 palpable breast cancer planned for neoadjuvant chemotherapy and who are candidates for breast-conserving surgery are ideal candidates.
Not a fit: Patients with inflammatory, T4, multicentric or multifocal disease, diffuse microcalcifications, ductal carcinoma in situ alone, recurrent or male breast cancer, or those unsuitable or unwilling for breast-conserving surgery are unlikely to benefit.
Why it matters
Potential benefit: If successful, pre-therapy tattooing (and clip use when needed) could increase the chances of breast-conserving surgery and reduce the need for mastectomy by improving intraoperative tumor localization.
How similar studies have performed: Previous small series and institutional reports have suggested that skin marking and clip localization are feasible and helpful for surgical planning, but large comparative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bhubaneswar, Odisha
- AIIMS Bhubaneswar — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Study coordinator: Mithilesh K Sinha, MS
- Email: surg_mithilesh@aiimsbhubaneswar.edu.in
- Phone: +919438884252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.