Breast CancerNCT06339658
ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
An observational study of Breast Cancer and Axillary Metastases, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Axillary Metastases
- What is being tested?
- Targeted axillary dissection (TAD) by ICG and Targeted axillary dissection (TAD) by Blue patent
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.
Who may be able to join
- Breast cancer cN+ patients who undergo neadjuvant treatment.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Amparo Garcia-Tejedor, MDPhD, 0034-660223417, agarciat@bellvitgehospital.cat
About this study
Official title: ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.
Read the detailed description
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.
- Conditions
- Breast Cancer, Axillary Metastases
- Being tested
- Targeted axillary dissection (TAD) by ICG, Targeted axillary dissection (TAD) by Blue patent
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted axillary dissection (TAD) by ICGProcedure or surgery
Use of ICG during the targeted axillary dissection (TAD)
Targeted axillary dissection (TAD) by Blue patentProcedure or surgery
Use of Blue patent during the targeted axillary dissection (TAD)
| Study group | Role | What they receive |
|---|---|---|
| Indocianine Green (ICG) | ICG tracer Receives: Procedure: Targeted axillary dissection (TAD) by ICG | |
| Blue patent | Blue patent tracer Receives: Procedure: Targeted axillary dissection (TAD) by Blue patent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
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
Measured: 2 years
Adverse effects
Evaluate the adverse effects from the use of each of the tracers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jan 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge
- Investigators
- Carlos Ortega-Expósito, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339658
- Sponsor's protocol ID
- TAD-ICG
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06339658
- Acronym / sponsor ID
- TAD-ICG
- Conditions
- Breast Cancer, Axillary Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indocianine Green (ICG) | – | Procedure: Targeted axillary dissection (TAD) by ICGICG tracer |
| Blue patent | – | Procedure: Targeted axillary dissection (TAD) by Blue patentBlue patent tracer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer cN+ patients who underwent neadjuvant treatment and will be candidates to perfom a targeted axillay dissection.
Key inclusion criteria (1 listed)
- Breast cancer cN+ patients who undergo neadjuvant treatment.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted axillary dissection (TAD) by ICGUse of ICG during the targeted axillary dissection (TAD) | Procedure or surgery | Indocianine Green (ICG) |
| Targeted axillary dissection (TAD) by Blue patentUse of Blue patent during the targeted axillary dissection (TAD) | Procedure or surgery | Blue patent |
Primary outcome
Detection rate of sentinel lymph node between tracers
Time frame: 2 years
Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment
2 secondary outcomes
Detection rate of SLNB with ICG versus Tc99
Time frame: 2 years
Adverse effects
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Ortega-Expósito principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Axillary Metastases, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amparo Garcia-Tejedor (0034-660223417, agarciat@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of sentinel lymph node between tracers (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.