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Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients

NCT07311278 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2025-12-30

No results posted yet for this study

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 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.

Conditions

Interventions

PROCEDURE

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

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

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.

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2025-10-30
Completion
2026-10-31

Countries

  • Italy
  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311278 on ClinicalTrials.gov