A study on improving the accuracy of cancer affected Lymph Node identification and removal in Breast Cancer patients undergoing surgery using marker clip and ink

Targeted Axillary Dissection using Marker Clip and India Ink - A Validation Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110975

Enrollment

105

Registered

2026-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: Clipping of FNAC positive Axillary Lymph Nodes and India Ink placement: Ultraclip Dual Trigger Catalogue 864017DL will be placed under ultrasound guidance India Ink will be injected wit

Eligibility

Inclusion criteria

Inclusion criteria: Patients with node positive Breast Cancer who are planned for Neoadjuvant Chemotherapy

Exclusion criteria

Exclusion criteria: 1. N3 disease as per the AJCC 9 th staging System 2. Patients who have undergone any axillary surgery in the past 3. Recurrent breast carcinoma 4. Refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
To determine the False Negative Rate of TAD using Marker Clip and India Ink in Post NACT Breast Cancer patientsTimepoint: 4 weeks after surgery	—

Secondary

Measure	Time frame
False Negative Rate for Clipped NodeTimepoint: 4 weeks post surgery;False Negative Rate for SLNB using dual dyeTimepoint: 4 weeks post surgery;Identification rate of SLNB using dual dyeTimepoint: At the time of surgery;Identification rate of the Tattooed nodeTimepoint: At the time of surgery;Axillary Pathological Complete Response RateTimepoint: 4 weeks after surgery	—

Countries

India

Contacts

Public ContactAmit Kumar Singh

Jawaharlal Institute of Postgraduate Medical Education and Research

pikachooa@gmail.com7838964296

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026