Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study

NCT04879680 | Completed

• 1 other identifier: CEFMS 82/2021
• Study Type: observational
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Radio Isotopes and Blue dye alone or in combination are the most commonly used tracer agents in sentinel Node Biopsy for early breast cancer. Recent studies have found fluorescence method using Indo Cyanine Green as a promising technology with fewer disadvantages. This study represents the first within a North African setting. Methods Retrospective analysis of our database that includes patients with clinically node-negative breast cancer scheduled for breast surgery and SN biopsy between 2016 and January 2021. Patients who underwent detection using fluorescence-ICG were included in this study.

Conditions

Breast Cancer; Sentinel Lymph Node

Keywords

breast cancer; sentinel node

Outcome Measures

Primary Outcomes (1)

• identification rate

  percentage of cas in whom sentinel node was identified with fluoresence method

  5 years

Interventions

sentinel node detection PROCEDURE

Under general anesthesia 5 ml at 2.5mg/ml of Infracyanine ® (Laboratoire SERB; France) were injected circumferentially around the areola. Two ml of patent blue-V dye (Laboratoire Guerbet, Aulney-Sous-Bois, France) were injected in combination in the cohort of patients undergoing the procedure after primary chemotherapy. This was followed by a breast massage to facilitate absorption into the lymph vessels, then the surgical lights were turned off and image were obtained under near-infrared light using a first generation Near Infra Red (NIR) device \[K\]. Course of subcutaneous lymphatic drainage pathway fluorescence was followed up to where it disappeared to enter to deeper axilla and an incision was performed at that place. Lymphatic duct identification using the NIR camera allowed localization and removal of the sentinel lymph node(s).

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

47 patients who underwent SN biopsy using the above-mentioned technique were included. Mean age at time of surgery was 50.1 years (range 24-78 years).

You may qualify if:

• non-pregnant or lacting adult female patients with breast cancer without palpable clinical node and considered suitable for such procedure at multidisciplinary meeting were included

You may not qualify if:

• Non eligible patient for breast cancer sentinel node procedure

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Samir Hidar, Prof. M.D

  F.Hached university teaching hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. M.D

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: April 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share