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

Recruiting

• Conditions: Axillary Metastases; Breast Cancer
• Interventions: Procedure: Targeted axillary dissection (TAD) by ICG; Procedure: Targeted axillary dissection (TAD) by Blue patent

• Registration Number: NCT06339658
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICG	Targeted axillary dissection (TAD) by ICG	ICG tracer
Blue patent	Targeted axillary dissection (TAD) by Blue patent	Blue patent tracer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse effects	2 years	Evaluate the adverse effects from the use of each of the tracers
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

Trial Locations

Locations (1)

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain