Breast CancerINFLUENCE IINCT07311278
Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients
A study testing Phase I: Technetium is administered as single tracer to identify the SLN (current standard)., Phase II: SLN biopsy using double tracer technetium and ICG (learning curve) and Phase III: ICG is administered as single tracer to identify the SLN (alternative method). in people with Breast Cancer, run by St. Antonius Hospital at 11 sites in 2 countries.
Trial summary
This study aims to evaluate the (inter)national implementation of a new diagnostic method for sentinel lymph node (SLN) detection in breast cancer. While Technetium-99m (99mTc) is the current gold standard for SLN detection, it has drawbacks such as limited availability, logistical challenges, radiation exposure, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Phase I: Technetium is administered as single tracer to identify the SLN (current standard)., Phase II: SLN biopsy using double tracer technetium and ICG (learning curve) and Phase III: ICG is administered as single tracer to identify the SLN (alternative method).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 8 Jun 2023to Oct 2026
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically node-negative, DCIS or invasive breast cancer confirmed by biopsy
- Preoperative axillary ultrasound to confirm clinical node-negative status
- Indication for breast cancer surgery with SLNB via axillar incision
- Written informed consent according to ICH/GCP and national regulations.
Who cannot join
- Patients < 18 years old.
- Indication for breast cancer surgery with SLNB via mastectomy incision
- Combined MARI procedure
- Known allergy for Indocyanine Green (ICG) or intravenous contrast or iodine
- History of axillary lymph node dissection
- Hyperthyroidism or thyroid cancer
- Pregnancy or breast-feeding
- Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Netherlands10 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
FlevoZiekenhuis
Almere Stad
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam
Reinier de Graaf Gasthuis
Delft
Van Weel-Bethesda Ziekenhuis
Dirksland
Maastricht Universitair Medisch Centrum
Maastricht
Erasmus Medisch Centrum
Rotterdam
HagaZiekenhuis
The Hague
Bernhoven Ziekenhuis
Uden
Isala Ziekenhuis
Zwolle
About this study
Official title: Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation Study.
This study aims to evaluate the (inter)national implementation of a new diagnostic method for sentinel lymph node (SLN) detection in breast cancer. While Technetium-99m (99mTc) is the current gold standard for SLN detection, it has drawbacks such as limited availability, logistical challenges, radiation exposure, and potential side effects. Extensive research indicates that Indocyanine Green (ICG) is an equally effective and potentially more practical alternative. Conducting this study will help accelerate the implementation of ICG in clinical practice.
Read the detailed description
An important part of oncological treatment for breast cancer is determining the lymph node status. A commonly used method for this is the sentinel lymph node (SLN) procedure. Analysis of this node plays a key role in determining both treatment and prognosis.
Currently, the gold standard for SLN localization is the use of Technetium-99m (99mTc). However, this method has several disadvantages. Since not every hospital has a Nuclear Medicine Department, patients often need to be referred to another facility for 99mTc injection and nuclear imaging. This process can be burdensome for patients and poses logistical challenges when scheduling surgeries. In addition, the use of 99mTc involves exposure to radioactive material, and adverse effects such as allergic reactions have been reported. Recent studies have shown that the use of Indocyanine Green (ICG) is equally effective for sentinel lymph node localization as Technetium.
The aim of this study is to evaluate the national and international implementation process of a new diagnostic method for SLN detection.
- Conditions
- Breast Cancer
- Being tested
- Phase I: Technetium is administered as single tracer to identify the SLN (current standard)., Phase II: SLN biopsy using double tracer technetium and ICG (learning curve), Phase III: ICG is administered as single tracer to identify the SLN (alternative method).
- Keywords
- indocyanine green, fluorescence, sentinel lymph node biopsy, sentinel lymph node mapping, sentinel lymph node procedure, ICG, implementation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I: Technetium is administered as single tracer to identify the SLN (current standard).Procedure or surgery
During this phase, surgeons will use technetium to identify the SLN as this is the current standard of care. This phase will serve as a control group.
Phase II: SLN biopsy using double tracer technetium and ICG (learning curve)Procedure or surgery
During this phase, surgeons will primarily use ICG to identify the sentinel lymph node (SLN), while technetium will serve as a control. This approach allows surgeons to gain proficiency with ICG-guided SLN biopsy and safely advance through the learning curve.
Phase III: ICG is administered as single tracer to identify the SLN (alternative method).Procedure or surgery
During this phase, surgeons will use ICG as a singe tracer to identify the SLN.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: pre-implemtation phase | Other | SLN biopsy using single tracer techentium (current standard) Receives: Procedure: Phase I: Technetium is administered as single tracer to identify the SLN (current standard). |
| Phase II: transition phase | Other | SLN biopsy using double tracer technetium and ICG (learning curve) Receives: Procedure: Phase II: SLN biopsy using double tracer technetium and ICG (learning curve) |
| Phase III: post-implementation phase | Other | SLN biopsy using single tracer ICG (alternative method) Receives: Procedure: Phase III: ICG is administered as single tracer to identify the SLN (alternative method). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifaction rate
Identification rate is defined as the proportion of patients in whom lymph nodes were identified with the gamma-probe using technetium or the fluorescent signal of ICG.
Measured: Perioperatively
Secondary outcomes (10)
Number of lymph nodes identified
This indicates the total number of lymph nodes identified with ICG or technetium.
Measured: Perioperatively
Percentage of SLNs identified per tracer
Percentage of SLNs that had technetium uptake / were fluorescent.
Measured: Perioperatively
Pathology assesment per SLN
The pathology of the identified SLN during surgery
Measured: Perioperatively
Detection time
Time in minutes to excise the SLN, measured from start of SLN procedure until detection of the first SLN.
Measured: Intraoperatively
Complications
Complications including (wound)infection, bleeding, seroma, and mild allergic reaction.
Measured: From the time of the SLN procedure up until three weeks of follow-up.
Adverse events
Number of adverse events attributable to technetium or ICG.
Measured: Monitored during study period until one year of follow-up
Locoregional recurrence at 1 year follow-up
Measured: Until the end of the study (after 1 year of follow-up)
Surgeon's expectations regarding ICG
Expectations of the participating surgeons regarding the use of ICG for SLN procedure using a study-specific survey with open-ended questions and multiple choice items.
Measured: Pre-implementation (prior to the transion phase)
Surgeons' experiences regarding ICG
Experiences of the participating surgeons regarding the use of ICG for SLN procedure using a study-specific survey with open-ended questions and multiple choice items.
Measured: Up to 12 months after transition to ICG as single tracer
Learning curve per surgeon
The learning curve process will be expressed by visualizing inter-surgeon variability in the number of procedures required to achieve proficiency portrayed in a scatterplot.
Measured: From each surgeon's first procedure using the double tracer method (technetium and ICG) through completion of the transition phase, assessed over up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start8 Jun 2023
- Primary completion30 Oct 2025
- Study completionOct 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 493 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tessa Dinger, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311278
- Sponsor's protocol ID
- NL79223.100.22
- Acronym
- INFLUENCE II
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation Study.
- ClinicalTrials.gov ID
- NCT07311278
- Acronym / sponsor ID
- INFLUENCE II / NL79223.100.22
- Conditions
- Breast Cancer
- Keywords
- indocyanine green, fluorescence, sentinel lymph node biopsy, sentinel lymph node mapping, sentinel lymph node procedure, ICG, implementation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 493 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
This study aims to evaluate the (inter)national implementation of a new diagnostic method for sentinel lymph node (SLN) detection in breast cancer. While Technetium-99m (99mTc) is the current gold standard for SLN detection, it has drawbacks such as limited availability, logistical challenges, radiation exposure, and potential side effects. Extensive research indicates that Indocyanine Green (ICG) is an equally effective and potentially more practical alternative. Conducting this study will help accelerate the implementation of ICG in clinical practice.
Detailed description
An important part of oncological treatment for breast cancer is determining the lymph node status. A commonly used method for this is the sentinel lymph node (SLN) procedure. Analysis of this node plays a key role in determining both treatment and prognosis.
Currently, the gold standard for SLN localization is the use of Technetium-99m (99mTc). However, this method has several disadvantages. Since not every hospital has a Nuclear Medicine Department, patients often need to be referred to another facility for 99mTc injection and nuclear imaging. This process can be burdensome for patients and poses logistical challenges when scheduling surgeries. In addition, the use of 99mTc involves exposure to radioactive material, and adverse effects such as allergic reactions have been reported. Recent studies have shown that the use of Indocyanine Green (ICG) is equally effective for sentinel lymph node localization as Technetium.
The aim of this study is to evaluate the national and international implementation process of a new diagnostic method for SLN detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I: pre-implemtation phase | Other | Procedure: Phase I: Technetium is administered as single tracer to identify the SLN (current standard).SLN biopsy using single tracer techentium (current standard) |
| Phase II: transition phase | Other | Procedure: Phase II: SLN biopsy using double tracer technetium and ICG (learning curve)SLN biopsy using double tracer technetium and ICG (learning curve) |
| Phase III: post-implementation phase | Other | Procedure: Phase III: ICG is administered as single tracer to identify the SLN (alternative method).SLN biopsy using single tracer ICG (alternative method) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically node-negative, DCIS or invasive breast cancer confirmed by biopsy
- Preoperative axillary ultrasound to confirm clinical node-negative status
- Indication for breast cancer surgery with SLNB via axillar incision
- Written informed consent according to ICH/GCP and national regulations.
Key exclusion criteria (8 listed)
- Patients < 18 years old.
- Indication for breast cancer surgery with SLNB via mastectomy incision
- Combined MARI procedure
- Known allergy for Indocyanine Green (ICG) or intravenous contrast or iodine
- History of axillary lymph node dissection
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 |
|---|---|---|
| Phase I: Technetium is administered as single tracer to identify the SLN (current standard).During this phase, surgeons will use technetium to identify the SLN as this is the current standard of care. This phase will serve as a control group. | Procedure or surgery | Phase I: pre-implemtation phase |
| Phase II: SLN biopsy using double tracer technetium and ICG (learning curve)During this phase, surgeons will primarily use ICG to identify the sentinel lymph node (SLN), while technetium will serve as a control. This approach allows surgeons to gain proficiency with ICG-guided SLN biopsy and safely advance through the learning curve. | Procedure or surgery | Phase II: transition phase |
| Phase III: ICG is administered as single tracer to identify the SLN (alternative method).During this phase, surgeons will use ICG as a singe tracer to identify the SLN. | Procedure or surgery | Phase III: post-implementation phase |
Primary outcome
Identifaction rate
Time frame: Perioperatively
Identification rate is defined as the proportion of patients in whom lymph nodes were identified with the gamma-probe using technetium or the fluorescent signal of ICG.
10 secondary outcomes
Number of lymph nodes identified
Time frame: Perioperatively
Percentage of SLNs identified per tracer
Time frame: Perioperatively
Pathology assesment per SLN
Time frame: Perioperatively
Detection time
Time frame: Intraoperatively
Complications
Time frame: From the time of the SLN procedure up until three weeks of follow-up.
Adverse events
Time frame: Monitored during study period until one year of follow-up
Locoregional recurrence at 1 year follow-up
Time frame: Until the end of the study (after 1 year of follow-up)
Surgeon's expectations regarding ICG
Time frame: Pre-implementation (prior to the transion phase)
Surgeons' experiences regarding ICG
Time frame: Up to 12 months after transition to ICG as single tracer
Learning curve per surgeon
Time frame: From each surgeon's first procedure using the double tracer method (technetium and ICG) through completion of the transition phase, assessed over up to 12 months.
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 30 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I: Technetium is administered as single tracer to identify the SLN (current standard)., Phase II: SLN biopsy using double tracer technetium and ICG (learning curve) and Phase III: ICG is administered as single tracer to identify the SLN (alternative method). in people with Breast Cancer, run by St. Antonius Hospital at 11 sites in 2 countries.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands, Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifaction rate (time frame: Perioperatively). 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 30 Dec 2025.