ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy

This patient registry is designed to prospectively collect standardized clinical, imaging, surgical, and pathological data from patients with cN1 breast carcinoma undergoing targeted axillary dissection (TAD) following neoadjuvant chemotherapy, using indocyanine green (ICG) as a lymphatic tracer.

To ensure data quality and consistency the following procedures and quality control measures will be implemented:

Standardized Case Report Forms (CRFs):

All data will be recorded using electronic CRFs developed specifically for the registry. These forms are structured to capture relevant demographic, clinical, radiological, surgical, and pathological variables, including tracer detection rates, number of retrieved nodes, false-negative rates, and complications.

Center Training and Accreditation:

All participating surgeons and radiologists will receive training on standardized procedures for TAD using ICG, including injection technique, intraoperative fluorescence detection, and specimen handling. Regular inter-institutional meetings will be held to reinforce protocol adherence.

Quality Assurance in Imaging and Pathology:

Lymph node localization procedures (e.g., clip placement, imaging review) and histopathological analyses will follow unified protocols.

Ethics and Patient Confidentiality:

All data will be de-identified and managed in compliance with GDPR and local data protection regulations. Informed consent will be obtained from each participant prior to data inclusion.

Follow-up and Outcome Tracking:

The registry will track short- and mid-term surgical outcomes, including detection rates, surgical complications, and axillary recurrence, ensuring longitudinal quality assessment of the ICG-guided TAD approach.

• Targeted axillary dissection (TAD) by ICG (Procedure): Use of ICG during the targeted axillary dissection (TAD)
• Targeted axillary dissection (TAD) by Blue patent (Procedure): Use of Blue patent during the targeted axillary dissection (TAD)

Primary outcomes

• Detection rate of sentinel lymph node between tracers [2 years]: Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment

Secondary outcomes

• Detection rate of SLNB with ICG versus Tc99 [2 years]: Compare the detection rate of sentinel lymph node between ICG and Tc99 in cN+ patients after neoadjuvant treatment
• Adverse effects [2 years]: Evaluate the adverse effects from the use of each of the tracers

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Breast cancer cN+ patients who undergo neadjuvant treatment.

Exclusion Criteria:

* Patients in whom there is a contraindication for the use of ICG.
* Patients in whom there is evidence of progression of the disease after neoadjuvant treatment.

• Carlos Ortega-Expósito, Principal investigator, Hospital Universitari de Bellvitge