Women above the age of 21 with core biopsy or cytology proven breast cancer stage I and II, eligible for lumpectomy and sentinel lymph node procedure MedDRA version: 9.1 Level: LLT Classification code 10006194 Term: Breast cancer NOS stage I MedDRA version: 9.1 Level: LLT Classification code 10006195 Term: Breast cancer NOS stage II
Conditions
Interventions
Trade Name: ICG-PULSION
Product Name: ICG Pulsion
Pharmaceutical Form: Emulsion for injection
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women above 21 years of age with stage I-II breast cancer diagnosed preoperatively by core biopsy or cytology and who have given informed consent according to the rules of the hospital. Patient is undergoing sentinel lymph node mapping for staging and treatment of their disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Refusal of the patient to be included in the study. 2. Pregnant or breast-feeding. 3. History of iodine allergy or anaphylactic reactions to insect bites or medication. 4. Presence or history of hyperthyroidism. 5. Recent surgery on the armpit. 6. Significant renal (serum creatinine = 400 µmol/L) dysfunction. 7. Cardiac and/or pulmonary disease (ASA III-IV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and patent blue) in detecting sentinel lymph nodes in breast surgery. ;Secondary Objective: The number of lymph nodes detected by ICG enhanced NIRF imaging during breast surgery. ;Primary end point(s): Whether ICG enhanced NIRF imaging is able to detect sentinel lymph nodes as good as or better than the standard technique (technetium-99 labeled colloid and patent blue) during breast surgery in 97%± 2% of the cases. | — |
Countries
Netherlands
Outcome results
None listed