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NCT06339658 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06339658
Other study ID # TAD-ICG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2026

Study information
Verified date April 2024
Source Hospital Universitari de Bellvitge
Contact Amparo Garcia-Tejedor
Phone 0034-660223417
Email agarciat@bellvitgehospital.cat
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 43
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Targeted axillary dissection (TAD) by ICG
Use of ICG during the targeted axillary dissection (TAD)
• Targeted axillary dissection (TAD) by Blue patent
Use of Blue patent during the targeted axillary dissection (TAD)

Locations
Country Name City State
Spain Hospital de Bellvitge Hospitalet de Llobregat Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection rate of sentinel lymph node Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment 2 years
Secondary Detection rate of sentinel lymph node Compare the detection rate of sentinel lymph node between ICG and Tc99 in cN+ patients after neoadjuvant treatment 2 years
Secondary Adverse effects Evaluate the adverse effects from the use of each of the tracers 2 years
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