ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted axillary dissection (TAD) by ICG, Targeted axillary dissection (TAD) by Blue patent.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Axillary Metastases. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
Overview
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.
Interventions
- Procedure Targeted axillary dissection (TAD) by ICG
Use of ICG during the targeted axillary dissection (TAD) - Procedure Targeted axillary dissection (TAD) by Blue patent
Use of Blue patent during the targeted axillary dissection (TAD)
Primary outcome measures
- Detection rate of sentinel lymph node between tracers [Time frame: 2 years]
Secondary outcome measures (2)
- Detection rate of SLNB with ICG versus Tc99 [Time frame: 2 years]
- Adverse effects [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital de Bellvitge — L'Hospitalet de Llobregat
Identifiers
NCT: NCT06339658 · TAD-ICG