Mastectomy Clinical Trials

Clinical trials related to Mastectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
AIIMS Bhubaneswar
RECRUITING
Bhubaneswar
Contact Information
Primary
Mithilesh K Sinha, MS
surg_mithilesh@aiimsbhubaneswar.edu.in
+919438884252
Backup
Banothu Raju, MBBS
banothu905@gmail.com
+917993575975
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2028-02-09
Participants
Target number of participants: 30
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences, Bhubaneswar

This content was sourced from clinicaltrials.gov