Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients (INFLUENCE II)

May 6, 2026 updated by: Casa di Cura Dott. Pederzoli

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Peschiera del Garda, Verona, Italy
        • Recruiting
        • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 99mTc
radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)
Procedure: technetium 99 used as a tracer for sentinel lymph node
technetium 99 used as a tracer for sentinel lymph node instead of ICG
Experimental: ICG
indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)
Procedure: ICG used as a tracer for sentinel lymph node
ICG used as a tracer for sentinel lymph node instead of technetium 99

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of SLNs that has 99mTc uptake/ is fluorescent
Time Frame: through study completion, an average of 1 year
Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%)
through study completion, an average of 1 year
Detection time
Time Frame: through study completion, an average of 1 year
Detection time is defined as time between skin incision and SLN resection in minutes (min)
through study completion, an average of 1 year
Total operative time
Time Frame: through study completion, an average of 1 year
Registration of the duration of the total surgical procedure including the SN-procedure (min or h)
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
registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding
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
number of regional loco recurrences assessed through clinical examinations
through study completion, an average of 1 year
The pathology of SLNs identified
Time Frame: through study completion, an average of 1 year
number of micro and macro metastases and isolated tumor cells (ITCs)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa di Cura Dott. Pederzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 418CET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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