Comparing ICG and Blue Patent for Axillary Dissection in Breast Cancer
Official title: ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
Run by Hospital Universitari de Bellvitge · NCT06339658 · Data updated 2026-11-12
This study is testing whether a special dye called indocyanine green (ICG) works better than the traditional blue dye during surgery to remove lymph nodes in breast cancer patients who have already had chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 43 (estimated) |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT06339658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with clinically node-positive breast cancer who have undergone neoadjuvant chemotherapy.
✕Probably not a fit
Patients with contraindications for ICG use or evidence of disease progression after neoadjuvant treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate the use of indocyanine green (ICG) as a tracer during targeted axillary dissection (TAD) in patients with clinically node-positive (cN1) breast carcinoma following neoadjuvant chemotherapy. It will prospectively collect standardized clinical, imaging, surgical, and pathological data to assess the effectiveness of ICG compared to the traditional Blue Patent method. Participating surgeons and radiologists will undergo training to ensure adherence to standardized procedures, and data quality will be maintained through electronic case report forms and regular inter-institutional meetings.
Why it matters
Potential benefit: If successful, this study could improve the accuracy and outcomes of axillary dissection in breast cancer patients.
How similar studies have gone: Other studies have shown promising results with ICG as a tracer in similar surgical contexts, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Carlos Ortega-Expósito — Hospital Universitari de Bellvitge
- Study coordinator: Amparo Garcia-Tejedor
- Email: agarciat@bellvitgehospital.cat
- Phone: 0034-660223417
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.