Malignant melanoma
Conditions
Interventions
The agent for the NIR imaging was prepared as follows. Human serum albumin (5 mg), indocyanine green (ICG
Diano-green
Daichi Pharmaceutical, Tokyo, Japan)(0.6 mg) and Patent Blue (Wako Pure Chemical Industries, Ltd.) (6 mg) were dissolved in 1 mL of pure water. The ICG was visualized using a fluorescence imaging syst
PDE, Hamamatsu Photonics, Japan) that includes a small charge-coupled-device camera with an integrated near-infrared (NIR) LED light source (energy: 4 mW
wavelength: 760 nm). An 820-nm band-path filter was employed to collect NIR radiation and to reject visible light. The fluorescence signals were sent to a digital video processor for display on a TV m
Sponsors
Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary cutaneous malignant melanoma lesions with more than 1mm thickness or lesions estimated to be at Clark level IV, V. The tumor thickness was estimated by clinical features, dermoscopic findings and images of echogram, CT or MRI.
Exclusion criteria
Exclusion criteria: Patients with PCMM apparently <1.0 mm thick clinically were excluded. Patients with apparent regional lymph node involvement were excluded. Patients in whom apparent metastatic lesions were found by physical and imaging examinations were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphatic flow changes after sentinel lymph node biopsy. The times between SLNB and the second NIR imaging were from 22 days to 786 days (average: 101.6 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and efficacy of sentinel lymph node biopsy | — |
Countries
Japan
Contacts
Public ContactKenji Yokota
Nagoya University Graduate School of Medicine Department of Dermatology
Outcome results
None listed