Breast CancerINFLUENCE IINCT07441733
Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients
A study testing ICG used as a tracer for sentinel lymph node and technetium 99 used as a tracer for sentinel lymph node in people with Breast Cancer, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial summary
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ICG used as a tracer for sentinel lymph node and technetium 99 used as a tracer for sentinel lymph node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2024to 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically node-negative, DCIS or invasive stage T1-T3 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 national regulations
Who cannot join
- Patients < 18 years old.
- Indication for breast cancer surgery with SLNB via mastectomy incision
- Known allergy for ICG, intravenous contrast or iodine
- History of axillary lymph node dissection
- Pregnancy or breast-feeding
- Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona
Francesca Guerini, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
Official title: INFLUENCE II - a Pilot Study for Implementation Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively FLUorEsceNt Imaging Using indoCyaninE Green: a Pilot Study for Implementation
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Read the detailed description
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.
Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
- Conditions
- Breast Cancer
- Being tested
- ICG used as a tracer for sentinel lymph node, technetium 99 used as a tracer for sentinel lymph node
- Keywords
- breast cancer, lymph node, 99mTc, ICG
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG used as a tracer for sentinel lymph nodeProcedure or surgery
ICG used as a tracer for sentinel lymph node instead of technetium 99
technetium 99 used as a tracer for sentinel lymph nodeProcedure or surgery
technetium 99 used as a tracer for sentinel lymph node instead of ICG
| Study group | Role | What they receive |
|---|---|---|
| 99mTc | Active comparator | radioisotope technetium technique will be used for sentinel lymph node localization(99mTc) Receives: Procedure: technetium 99 used as a tracer for sentinel lymph node |
| ICG | Experimental | indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG) Receives: Procedure: ICG used as a tracer for sentinel lymph node |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Percentage of SLNs that has 99mTc uptake/ is fluorescent
Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%)
Measured: through study completion, an average of 1 year
Detection time
Detection time is defined as time between skin incision and SLN resection in minutes (min)
Measured: through study completion, an average of 1 year
Total operative time
Registration of the duration of the total surgical procedure including the SN-procedure (min or h)
Measured: through study completion, an average of 1 year
Number of complications and (serious) adverse events
registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding
Measured: through study completion, an average of 1 year
loco regional recurrence after 1 year follow-up
number of regional loco recurrences assessed through clinical examinations
Measured: through study completion, an average of 1 year
The pathology of SLNs identified
number of micro and macro metastases and isolated tumor cells (ITCs)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start7 Nov 2024
- Primary completion31 Mar 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The golden standard for obtaining the sentinel lymph node (SLN) in patients with breast cancer currently is radio guided surgery with radioisotope technetium (99mTc). However, the use of 99mTc-nanocolloid presents logistical challenges and contributes to patient burden. A proven effective and safe alternative is fluorescence imaging using indocyanine green (ICG).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441733
- Sponsor's protocol ID
- 418CET
- Acronym
- INFLUENCE II
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLUENCE II - a Pilot Study for Implementation Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively FLUorEsceNt Imaging Using indoCyaninE Green: a Pilot Study for Implementation
- ClinicalTrials.gov ID
- NCT07441733
- Acronym / sponsor ID
- INFLUENCE II / 418CET
- Conditions
- Breast Cancer
- Keywords
- breast cancer, lymph node, 99mTc, ICG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Mar 2026 (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 single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Detailed description
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.
Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The golden standard for obtaining the sentinel lymph node (SLN) in patients with breast cancer currently is radio guided surgery with radioisotope technetium (99mTc). However, the use of 99mTc-nanocolloid presents logistical challenges and contributes to patient burden. A proven effective and safe alternative is fluorescence imaging using indocyanine green (ICG).
| Arm | Type | Receives |
|---|---|---|
| 99mTc | Active comparator | Procedure: technetium 99 used as a tracer for sentinel lymph noderadioisotope technetium technique will be used for sentinel lymph node localization(99mTc) |
| ICG | Experimental | Procedure: ICG used as a tracer for sentinel lymph nodeindocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically node-negative, DCIS or invasive stage T1-T3 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 national regulations
Key exclusion criteria (6 listed)
- Patients < 18 years old.
- Indication for breast cancer surgery with SLNB via mastectomy incision
- Known allergy for ICG, intravenous contrast or iodine
- History of axillary lymph node dissection
- Pregnancy or breast-feeding
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 |
|---|---|---|
| ICG used as a tracer for sentinel lymph nodeICG used as a tracer for sentinel lymph node instead of technetium 99 | Procedure or surgery | ICG |
| technetium 99 used as a tracer for sentinel lymph nodetechnetium 99 used as a tracer for sentinel lymph node instead of ICG | Procedure or surgery | 99mTc |
Primary outcome
Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
Time frame: through study completion, an average of 1 year
measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)
6 secondary outcomes
Percentage of SLNs that has 99mTc uptake/ is fluorescent
Time frame: through study completion, an average of 1 year
Detection time
Time frame: through study completion, an average of 1 year
Total operative time
Time frame: through study completion, an average of 1 year
Number of complications and (serious) adverse events
Time frame: through study completion, an average of 1 year
loco regional recurrence after 1 year follow-up
Time frame: through study completion, an average of 1 year
The pathology of SLNs identified
Time frame: through study completion, an average of 1 year
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 11 May 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
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.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG used as a tracer for sentinel lymph node and technetium 99 used as a tracer for sentinel lymph node in people with Breast Cancer, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
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 6 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 11 May 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG (time frame: through study completion, an average of 1 year). 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 11 May 2026.