NCT06339658

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

March 25, 2024

Last Update Submit

April 17, 2025

Conditions

Breast CancerAxillary Metastases

Outcome Measures

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

    2 years

Secondary Outcomes (2)

  • Detection rate of SLNB with ICG versus Tc99

    2 years

  • Adverse effects

    2 years

Study Arms (2)

Indocianine Green (ICG)

ICG tracer

Procedure: Targeted axillary dissection (TAD) by ICG

Blue patent

Blue patent tracer

Procedure: Targeted axillary dissection (TAD) by Blue patent

Interventions

Targeted axillary dissection (TAD) by ICGPROCEDURE

Use of ICG during the targeted axillary dissection (TAD)

Indocianine Green (ICG)
Targeted axillary dissection (TAD) by Blue patentPROCEDURE

Use of Blue patent during the targeted axillary dissection (TAD)

Blue patent

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.

You may qualify if:

  • Breast cancer cN+ patients who undergo neadjuvant treatment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DAT protocol 1

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carlos Ortega-Expósito

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amparo Garcia-Tejedor

CONTACT

0034-660223417agarciat@bellvitgehospital.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

January 1, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations

ES(1)