A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer
Conditions
Interventions
Trade Name: Pulsion
Product Name: Pulsion
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Indocyaningreen
CAS Number: 3599-32-4
Current Sponsor code: ICG1
Other descri
Sponsors
Landeskrankenhaus Fedkirch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - biopsy proven invasive breast cancer in women of any age over 18 years of age - tumours measuring =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: women unable to provide informed consent - history of previous breast cancer - prior axillary surgery or breast excision biopsy - prior axillary surgery or a diagnostic excision biopsy of the breast - pregnant or lactating women - hypersensitivity to indocyanine green (ICG) or to sodium iodide - hypersensitivity to iodine - patients with hyperthyroidism or toxic thyroid adenomas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine sensitivity of ICG in sentinel lymph node identification if combined with blue dye and radiocolloid;Secondary Objective: in how many cases ICG could replace radiocolloid;Primary end point(s): Sensitivity of ICG fluorescence, defined as the number of sentinel nodes detected by conventional methods (blue dye, radio-isotope or combination) that are also fluorescent with ICG. ;Timepoint(s) of evaluation of this end point: Patients will have a wound inspection, and recording of any adverse events, at their first routine post-operative visit two weeks after surgery. There will be no additional visits required as part of this study after this visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): in how many cases radiocolloid could be replaces by ICG;Timepoint(s) of evaluation of this end point: Patients will have a wound inspection, and recording of any adverse events, at their first routine post-operative visit two weeks after surgery. There will be no additional visits required as part of this study after this visit | — |
Countries
Austria
Contacts
Public ContactAnton Haid
Landeskrankenhaus Feldkirch
Outcome results
None listed