Melanoma
Conditions
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: Melanoma 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
Secondary
| Measure | Time frame |
|---|---|
| 1. Median number of lymph nodes identified with ICG:HSA and standard SNB; 2. Identification rate of standard SNB; 3. Sensitivity: percentage of patients in whom fluorescent lymph nodes were identified of the total patients with identified sentinel lymph nodes by standard SNB technique; 4. Improvement in false-negative rate. | — |
Primary
| Measure | Time frame |
|---|---|
| Identification rate, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes was identified percutaneously with the fluorescent signal of ICG:HSA. | — |
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