Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients
Recruiting · NCT07441733 · Interventional (participants receive a specific treatment) · Lead sponsor: Casa di Cura Dott. Pederzoli
View the official record on ClinicalTrials.gov →Interventions studied
ICG used as a tracer for sentinel lymph nodetechnetium 99 used as a tracer for sentinel lymph node
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A. - Peschiera del Garda, Verona, Italy