breast cancer
Conditions
Interventions
A Randomized Single-Institution Superiority Trial comparing standard of care SLN (radioactive tracer and blue dye) + ICG fluorescence and SLN mapping using only radiocolloid (omitting patent blue) + I
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: Breast cancer patients planned to undergo a sentinel lymph node procedure.
Exclusion criteria
Exclusion criteria: 1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin; 2. Pregnancy; 3. Presence of 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 |
|---|---|
| Signal-to-background ratio of identified SLNs, defined as the fluorescence intensity of SLN divided by the fluorescence intensity of the surrounding background. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of identified SLNs: fluorescence and non-fluorescence; 2. In vivo and ex vivo fluorescence intensity of SLNs; 3. Identification ratio; 4. Percutaneous lymphatic channel identification; 5. Time to identification of SLN. | — |
Contacts
Public ContactC.J.H. Velde, van de
Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600
Outcome results
None listed