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Comparison of Fluorescein plus blue dye and blue dye alone in sentinel lymph node biopsy of breast cancer patients after neoadjuvant chemotherapy

Sentinel Lymph Node Biopsy in Post Neoadjuvant Chemotherapy Breast Cancer Patients Using Combination of Fluorescein and Blue Dye Versus Blue Dye Alone - A Randomized Controlled Trial - SLNBPNACTFB

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028337
Enrollment
60
Registered
2020-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Sentinel Lymph node biopsy by fluorescein and methylene blue: In the fluorescein and methylene blue arm, one ml of 20% fluorescein diluted with 4 ml of normal saline will be injected in

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Post NACT, node negative breast cancer patients who are planned for surgery 2. Those who are accepted to participate in the study and gives consent 3. Between 18 and 90 years of age. 4. ECOG performance status 0-1

Exclusion criteria

Exclusion criteria: 1. Prior surgical procedures that have the potential to substantially alter the lymphatic drainage pattern from the primary tumor to the lymph node basin. 2. Allergy to fluorescein /methylene blue 3. Pregnant or lactating women 4. Renal failure / Renal parenchymal disease patients

Design outcomes

Primary

MeasureTime frame
-SLN Identification rate and false negative rate by using fluorescein and methylene blue in comparison to methylene blue aloneTimepoint: 1) during intraoperative time (baseline) 2) whenever final biopsy is ready ( approximately 10 days)

Secondary

MeasureTime frame
- Impact of Preoperative axillary ultrasonography of axilla in decision making for sentinel lymph node biopsyTimepoint: postoperative period ( 15 days)

Countries

India

Contacts

Public ContactByshetty Rajendar

AIIMS , JODHPUR

drjvishnoi@gmail.com9455061569

Outcome results

None listed

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