Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively Fluorescent Imaging Using Indocyanine Green: an International Multicenter Implementation Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- St. Antonius Hospital
- Enrollment
- 493
- Locations
- 11
- Primary Endpoint
- Identifaction rate
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of lymph nodes identified(Perioperatively)
- Percentage of SLNs identified per tracer(Perioperatively)
- Pathology assesment per SLN(Perioperatively)
- Detection time(Intraoperatively)
- Learning curve per surgeon(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.)
- Complications(From the time of the SLN procedure up until three weeks of follow-up.)
- Adverse events(Monitored during study period until one year of follow-up)
- Surgeons' experiences regarding ICG(Up to 12 months after transition to ICG as single tracer)
- Locoregional recurrence at 1 year follow-up(Until the end of the study (after 1 year of follow-up))
- Surgeon's expectations regarding ICG(Pre-implementation (prior to the transion phase))
Investigators
Tessa Dinger
Medical Doctor
St. Antonius Hospital