melanoma
Conditions
Interventions
Control group 1:Within 24 hours prior to surgery, Technetium [99mTc] Sulfur Colloid Injection (hereinafter referred to as radionuclide) was administered via multiple
Control group 2:After anesthesia and disinfection, 25 mg of Indocyanine Green for Injection (ICG) was reconstituted with 10 mL of normal saline, and 1 mL of the resul
Experimental group:During surgery, the blue-stained lymph nodes and those indicated by blue-stained lymphatic vessels were dissected and identified.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subject must be able to understand and voluntarily sign the written informed consent form (ICF). 2.Subjects aged between 18 and 75 years (inclusive of 18 and 75). 3. Patients with primary cutaneous melanoma, acral melanoma, or head and neck melanoma. 4. Patients with a Breslow thickness >= 0.8 mm or the presence of other unfavorable characteristics (e.g., ulceration, Clark level IV, nodular histologic subtype, increased mitotic rate, or regression phenomenon). 5. No clear contraindications to surgery based on routine preoperative evaluations. 6. Subjects without severe abnormalities in hematologic, hepatic, or renal function.
Exclusion criteria
Exclusion criteria: 1.Patients with mucosal melanoma, uveal melanoma, or head and neck melanoma. 2.Patients who have undergone wide local excision of the primary lesion or local reconstruction. 3.Patients with melanoma characterized by a Breslow thickness < 0.8 mm without ulceration (T1a) or other unfavorable features. 4. Subjects with severe hepatic or renal impairment. 5. Subjects with a positive pregnancy test or who are lactating. 6. Subjects considered unsuitable for participation in the trial at the investigator's discretion due to other reasons (e.g., poor compliance, presence of other serious diseases requiring concomitant treatment, severely abnormal laboratory values, infectious diseases, or family or social factors that may compromise subject safety or collection of trial data).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLN detection rate of MHI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation;SLN detection rate of ICG;Combined detection rate;SLN detection rate of radionuclide;Co-tracing rate; | — |
Countries
China
Contacts
Public ContactYu Xu
Fudan University Shanghai Cancer Center
Outcome results
None listed