Breast cancer
Conditions
Interventions
Trade Name: ICG-PULSION
Pharmaceutical Form: Injection*
CAS Number: 3599324
Other descriptive name: INDOCYANINE GREEN
Concentration unit: µmole/l micromole(s)/litre
Concentration type: equal
Concentra
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Breast cancer patients planned to undergo a sentinel lymph node procedure. - Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations. 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: - history of allergy to iodine, shellfish, indocyanine green or human serum albumin. - pregnancy - any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine to proportion of breast cancer patients in whom sentinel and non-sentinel lymph nodes can be identified non-invasively and percutaneously with fluorescent imaging using ICG:HSA during the sentinel lymph node procedure. ;Secondary Objective: To determine the number of lymph nodes identified with fluorescent compared to standard SNB.;Primary end point(s): Identification rate is defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes was identified percutaneously with the fluorescent signal of ICG:HSA. | — |
Countries
Netherlands
Outcome results
None listed