breast cancer sentinel node procedure
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
Exclusion criteria
Exclusion criteria: Pregnant women, significant renal (creatinine >, cardiac, or pulmonary disease (ASA III-IV), History of iodine allergy or anaphylactic reactions to insect bites or medication, presence or history of hyperthyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: • Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard Sentinel Lymph Node mapping procedure and used safely by the surgeon while detection of ICG takes place. Duration: 1,5 hour clinical procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): • The secondary endpoint of this feasibility study is the number and location of detected sentinel lymph nodes compared to the standard detection of sentinel lymph nodes with the use of patent blue and technetium-99 labelled colloid. | — |
Countries
Netherlands
Outcome results
None listed