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Evaluation of Indocyanine Green dye for sentinel lymph node biopsy in breast cancer

Evaluation of Indocyanine Green for sentinel lymph node biopsy in breast cancer: Two arm, Open label, Parallel design, Non-inferiority, Randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045719
Enrollment
70
Registered
2022-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Sentinel Lymph Node Biopsy using Indocyanine green dye(ICG): The agent used for sentinel lymph node biopsy in the intervention arm will be Indocyanine Green dye(ICG) at the time of surg

Sponsors

Department of Surgical Disciplines
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Upfront operable primary breast cancer measuring upto and including 5cm in maximum tumour dimension with clinically lymph node negative breast cancers (Tis, T1,T2-N0) undergoing upfront surgery Consenting patient

Exclusion criteria

Exclusion criteria: Pregnant or lactating women Patients who have received neo-adjuvant chemotherapy. Patients with history of previous surgery of axilla or chest wall. Patients with history of previous radiotherapy to the breast or axilla. H/o hypersensitivity to any of the agents used.

Design outcomes

Primary

MeasureTime frame
identification and comparison of sentinel lypmh node proportions using Indocyanine green with the standard radio colloid- methylene blue dye method.Timepoint: Baseline

Secondary

MeasureTime frame
Procedure time of doing sentinel lymph node biopsy from time of skin incision to identification of sentinel lymph node in each group.Timepoint: Baseline

Countries

India

Contacts

Public ContactDr Nandury Bhargav Chandra

All India Institute of Medical Sciences, New Delhi

drsuhani@gmail.com9868397697

Outcome results

None listed

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