Melanoma
Conditions
Interventions
A feasibility single-institution trial to assess the use of ICG combined with 99mTc-nanocolloid as a cocktail in SLN mapping in melanoma patients. Standard-of-care SLN mapping will be performed (blue
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
Primary
| Measure | Time frame |
|---|---|
| NIR fluorescence identification ratio of the SLN, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes were identified using NIR fluorescence. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Signal to background ratio of the SLNs; 2. Number of identified SLNs: fluorescence a nd non-fluorescence; 3. In vivo and ex vivo fluorescence intensity of SLNs and radioactivity of the SLNs; 4. Percutaneous lymphatic channel identification at multiple time points; 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