Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCasa di Cura Dott. Pederzoli

About this trial

This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.

Eligibility criteria

Qualifiers

Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy

Preoperative axillary ultrasound to confirm clinical node-negative status

Indication for breast cancer surgery with SLNB via axillar incision

Written informed consent according to national regulations

Disqualifiers

Patients < 18 years old.

Indication for breast cancer surgery with SLNB via mastectomy incision

Known allergy for ICG, intravenous contrast or iodine

History of axillary lymph node dissection

Trial design

Treatments tested in this trial

  • ICG used as a tracer for sentinel lymph node
  • technetium 99 used as a tracer for sentinel lymph node

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators