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Testing a Low-Cost and Simple Method using Fluorescein dye to Check Lymph Node metastasis in Early Breast Cancer

Fluorescein Sodium guided versus other tracer guided sentinel lymph node biopsy in patients with early breast cancer (FLUOSENT): A Randomized controlled trial - FLUOSENT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080832
Enrollment
264
Registered
2025-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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: Fluorescein Sodium + methylene blue guided SLNB: Patients will undergo FS with methylene blue guided SLNB Control Intervention1: Standard SLNB: Patients will undergo SLNB by other trace

Sponsors

NSCB Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with early breast cancer who have clinically and sonographically negative axilla (cN0)

Exclusion criteria

Exclusion criteria: Patients who are not consenting 2. Patients who are not candidate for SLNB.

Design outcomes

Primary

MeasureTime frame
sentinel lymph node identification rate (SLN-IR)Timepoint: Intra-operative

Secondary

MeasureTime frame
complicationsTimepoint: 30 days;duration of procedureTimepoint: after surgery;cost-effectiveness ratioTimepoint: Immediate

Countries

India, Nepal

Contacts

Public ContactSanjay Kumar Yadav

Netaji Subhash Chandra Bose Medical College

sky1508@gmail.com8127095090

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026