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A study to estimate the accuracy of Sentinel Lymph Node Biopsy using Methylene blue-Fluorescein dye combination in Post Neo-adjuvant Chemotherapy (NACT) Breast Cancer patients having no axillary Lymph node involvement (ycN0)

Sentinel Lymph Node Biopsy using Methylene blue-Fluorescein dye combination in Post Neo-adjuvant Chemotherapy Node Negative (ycN0) Breast Cancer patients: A Validation Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/081293
Enrollment
22
Registered
2025-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr Mayank Mishra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All breast cancer patients who are Node negative after NACT

Exclusion criteria

Exclusion criteria: 1) Patients with Inflammatory Breast Cancer 2) Patients with history of any radiation or prior surgery to the axillary lymphatic system 3) Patients with current or history of lymphedema of limb on the affected side 4) Patients who have allergy to tracer used

Design outcomes

Primary

MeasureTime frame
1)To calculate the Identification Rate (IR) of SLNB in ycN0 Breast cancer patients using Methylene blue-Fluorescein dye combination 2)To calculate the False Negative Rate (FNR) of SLNB in ycN0 Breast cancer patients using Methylene blue-Fluorescein dye combination Timepoint: Individual data to be collected once HPE reports of SLNB and ALND specimens available (15-20 days from date of surgery) Final outcome to be calculated at end of study (30/6/2025)

Secondary

MeasureTime frame
1) To quantify the average number of SLNs identified using Methylene blue-Fluorescein dye combination in post NACT patients of Breast CancerTimepoint: Individual data to be collected intra-operatively (on day of surgery) Final outcome to be calculated at end of study (30/6/2025)

Countries

India

Contacts

Public ContactDr Mayank Mishra

Department of General Surgery, All India Institute of Medical Sciences, Patna

drprashantks@aiimspatna.org8809645678

Outcome results

None listed

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