Skip to content

A clinical trial for comparison between combination of dyes to identify first draining lymph nodes in patients of Breast Cancer

Evaluation of Dual dye technique for sentinel lymph node biopsy in breast cancer: Two arm open label parallel design Non-inferiority Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023503
Enrollment
70
Registered
2020-02-21
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 Using Indocyanin Green And Methylene Blue: Five minutes after injection of methylene blue dye and before surgery, 5 mL of 1% Indocyanine green will be injecte
half of the volume (2.5ml) in peritumoral region and half in peri-areolar region. In case of non-palpable lesions, dye will be injected in the peri-areolar region. Then the breast will be massaged

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Upfront operable primary breast tumor measuring upto and including 5cm in maximum tumor dimension with clinically lymph node negative breast cancers (Tis, T1,T2-N0) 2. Consenting patient

Exclusion criteria

Exclusion criteria: 1. With T3, T4 lesions 2. Who are Pregnant, Lactating 3. Patients with history of previous radiotherapy to the breast or axilla 4. Patients with history of previous surgery of Axilla or chest wall 5. Patients who have received Neo-adjuvant chemotherapy 6. H/o hypersensitivity to any of the agents used 7. Not giving consent

Design outcomes

Primary

MeasureTime frame
- Detection proportion among both groups-Proportion of number of sentinel lymph nodes identified in each group Timepoint: 25/01/2020 to 30/11/2021

Secondary

MeasureTime frame
- Cost calculation and procedure time of doing SLNB in each groupTimepoint: 25/01/2020 to 30/11/2021

Countries

India

Contacts

Public ContactDr Utkarsh

All India Institute of Medical Sciences

drsuhani@gmail.com8586097123

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026