Comparison of 0.4ml vs 0.6 ml India Ink Solution for tattooing of axillary lymph nodes in patients with breast cancer

Comparison of 0.4 ml vs 0.6 ml diluted India ink solution for tattooing of axillary lymph nodes in the patient with breast cancer - a randomized controlled trial - TAXLYN Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062933

Enrollment

Registered

2024-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Tattooing of axillary lymph nodes with India ink 0.4 ml in patients with breast cancer.: Tattooing of axillary lymph nodes with India ink in patients with breast cancer, Stage T2-4, N1

Eligibility

Inclusion criteria

Inclusion criteria: a) CA Breast with TNM Stage- T2-4, N1. b) Clinically palpable axillary lymph nodes.

Exclusion criteria

Exclusion criteria: a) More than two discrete and enlarged axillary lymph nodes. b) Axillary lymph nodes - less than 1cm (difficult to hold) and more than 5 cm (targeting not practical). c) N stage -N2, N3. d) Inflammatory breast cancer e) B/L Breast cancer f) Male breast cancer g) Family history suggestive of BRCA1 and BRCA2 gene mutation.

Design outcomes

Primary

Measure	Time frame
comparison of Identification rates of tattooed tissue during modified radical mastectomy in two intervention arms.Timepoint: During mastectomy or day 0: for identification of tattooed nodes Follow up at daily till the day of discharge. 10th day for stitch removal 15th day for Histopathology review. One month: wound Evaluation Third Month: wound and axilla review. Sixth Month.	—

Secondary

Measure	Time frame
Response rate with neo- adjuvant chemotherapyTimepoint: At Three months from start of chemotherapy	—

Countries

India

Contacts

Public ContactDr Dhanalakshmi N

AIIMS BHUBANESWAR

mks132@gmail.com9438884252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026