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

Catalan Institute of Health

Status

Enrolling

Conditions

Breast Cancer

Axillary Metastases

Treatments

Procedure: Targeted axillary dissection (TAD) by ICG

Procedure: Targeted axillary dissection (TAD) by Blue patent

Study type

Observational

Funder types

Other

Identifiers

NCT06339658

TAD-ICG

Details and patient eligibility

About

To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.

Full description

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.

Enrollment

43 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.