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

ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Axillary Metastases
• Intervention / Treatment: Procedure: Targeted axillary dissection (TAD) by ICG; Procedure: Targeted axillary dissection (TAD) by Blue patent

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 Type: Observational
• Enrollment (Estimated): 43

Contacts and Locations

• Study Contact: Name: Amparo Garcia-Tejedor; Phone Number: 0034-660223417; Email: agarciat@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital De Bellvitge
      • Contact: Amparo Garcia-Tejedor, MDPhD; Phone Number: 0034-660223417; Email: agarciat@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blue patent; Blue patent tracer	Procedure: Targeted axillary dissection (TAD) by Blue patent; Use of Blue patent during the targeted axillary dissection (TAD)
Indocianine Green (ICG); ICG tracer	Procedure: Targeted axillary dissection (TAD) by ICG; Use of ICG during the targeted axillary dissection (TAD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of sentinel lymph node between tracers	Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Evaluate the adverse effects from the use of each of the tracers	2 years
Detection rate of SLNB with ICG versus Tc99	Compare the detection rate of sentinel lymph node between ICG and Tc99 in cN+ patients after neoadjuvant treatment	2 years

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Carlos Ortega-Expósito, Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TAD-ICG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No