Breast cancer, breast carcinoma Breast cancer
Conditions
Interventions
Phase I (pre-implementation): SLN procedure with the standard of care using Tc99, which implies Tc99 injection and lymphoscintigraphy the day or the morning before surgery, followed by radio-guided su
Phase II (transition period): SLN procedure using ICG and controlled by Tc99. Patients receive Tc99 injection and lymphoscintigraphy before surgery, with the surgeon blinded for imaging results. Durin
Phase III (post-implementation): SLN procedure using ICG as single tracer. 5 mg ICG (2 mL of a 2.5 mg/mL solution prepared by dissolving ICG in sterile water) will be injected periareolar after admini
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients >= 18 years old. • DCIS or invasive breast cancer, confirmed by biopsy • Clinically node-negative (cN0), confirmed by preoperative axillary ultrasound • Indication for breast cancer surgery with sentinel lymph node biospy via axillar incision • Written informed consent according to ICH/GCP and national regulations.
Exclusion criteria
Exclusion criteria: • Combined MARI procedure • Known allergy for Indocyanine Green (ICG), 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study endpoints are categorized into implementation outcomes (adoption, penetration, fidelity, appropriateness, feasibility and acceptability), intervention outcomes (effectiveness, safety, cost benefit), and patient-reported experience (patient satisfaction). The primary endpoint is penetration, which is an implementation outocome, and is defined as the proportion of SLN procedures conducted with ICG as a single tracer during Phase III, compared to the total SLN procedures in this phase using inlcusion and hospital records. | — |
Secondary
| Measure | Time frame |
|---|---|
| All other outcomes are secondary. Fidelity is measured through an intraoperative survey. Anticipated implementation outcomes such as appropriateness, feasibility, and acceptability are evaluated via a healthcare provider survey during Phase III using an embedded mixed-methods approach as the survey includes Likert scales, closed-ended questions, as well as free-text questions. Intervention outcomes encompass effectiveness, safety, cost benefit, evaluated using perioperative data and hospital administration data. Patient-reported experience evaluates patient satisfaction through a survey sent to patients following their SLN procedure. | — |
Countries
Netherlands
Contacts
Public ContactI.J. Henskens
St. Antonius Ziekenhuis
Outcome results
None listed