ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer cN+ patients who undergo neadjuvant treatment.
Disqualifiers
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.
Trial population
Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Targeted axillary dissection (TAD) by ICG
Procedure/SurgeryUse of ICG during the targeted axillary dissection (TAD)
Targeted axillary dissection (TAD) by Blue patent
Procedure/SurgeryUse of Blue patent during the targeted axillary dissection (TAD)
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: Indocianine Green (ICG)1 intervention
Group B: Blue patent1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 yearsSecondary outcomes
1
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
Time frame
2 years2
Adverse effects
Evaluate the adverse effects from the use of each of the tracers
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov