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

NCT ID: NCT06339658

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-01-01

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.

Conditions

Breast Cancer; Axillary Metastases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Indocianine Green (ICG)

ICG tracer

Targeted axillary dissection (TAD) by ICG

Intervention Type: PROCEDURE

Use of ICG during the targeted axillary dissection (TAD)

Blue patent

Blue patent tracer

Targeted axillary dissection (TAD) by Blue patent

Intervention Type: PROCEDURE

Use of Blue patent during the targeted axillary dissection (TAD)

Interventions

Targeted axillary dissection (TAD) by ICG

Use of ICG during the targeted axillary dissection (TAD)

Intervention Type: PROCEDURE

Targeted axillary dissection (TAD) by Blue patent

Use of Blue patent during the targeted axillary dissection (TAD)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Amparo Garcia-Tejedor

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Ortega-Expósito

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Amparo Garcia-Tejedor

Role: CONTACT

agarciat@bellvitgehospital.cat

0034-660223417

Facility Contacts

Amparo Garcia-Tejedor, MDPhD

Role: primary

agarciat@bellvitgehospital.cat

0034-660223417

Other Identifiers

TAD-ICG

Identifier Type: -

Identifier Source: org_study_id