Vulvar cancer
Conditions
Interventions
Standard SLNP will be performed. One day before surgery or the day of surgery. 99TC-Nanocoll-ICG will be injected and lymphatic pathways and lymph nodes will be visualized non-invasively and percutane
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Vulvar 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 |
|---|---|
| 1. The proportion of patients in whon sentinel and non-sentinel lymph nodes can be identified; 2. Difference in signal-to-background ratio between different injection groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Carrelation between fluorescent and radioactove nodes; 2. The correlation between the quantitative fluorescence signal and quantitative radioactive signal. | — |
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