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

NCT04879680 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2021-05-10

No results posted yet for this study

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

Interventions

PROCEDURE

sentinel node detection

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).

Sponsors & Collaborators

  • Faculty of Medicine, Sousse

    lead OTHER

Principal Investigators

  • Samir Hidar, Prof. M.D · F.Hached university teaching hospital

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-03-31
Completion
2021-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879680 on ClinicalTrials.gov