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To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocianine Green (ICG) | ICG tracer |
| |
| Blue patent | Blue patent tracer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted axillary dissection (TAD) by ICG | Procedure | Use of ICG during the targeted axillary dissection (TAD) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse effects | Evaluate the adverse effects from the use of each of the tracers |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amparo Garcia-Tejedor | Contact | 0034-660223417 | agarciat@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Ortega-Expósito | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C039418 | DAT protocol 1 |
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| Targeted axillary dissection (TAD) by Blue patent | Procedure | Use of Blue patent during the targeted axillary dissection (TAD) |
|
| 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |