Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study (LIMIT)
Malignant Melanoma, Merkel Cell Carcinoma
About this trial
This is an interventional diagnostic trial for Malignant Melanoma focused on measuring transcutaneous identification of SLNs with ICG
Eligibility Criteria
Inclusion Criteria:
Malignant melanoma patients having one of the following characteristics:
- Breslow score ≥ 1 mm
- Breslow score ≥ 0.7 mm associated with ulceration
- Breslow score ≥ 0.7 mm associated with regression
- Breslow score ≥ 0.7 mm associated with Clark Level IV / V
- Breslow score ≥ 0.7 mm associated with mitotic rate ≥ 1/mm2 in young patients
- Merkel cell carcinoma
Exclusion Criteria:
- Age < 18 years
- Pregnancy and breastfeeding (pregnancy test to be performed for women of child-bearing potential, defined as women who are not surgically sterilized/ hysterectomized, and/or who are postmenopausal for less than 12 months)
- Known allergy to ICG or Iodine
- Previous chemotherapy, radiotherapy or surgery to the lymph nodes of interest
- Lack of capacity to provide informed consent
- Current enrolment in any other interventional study
Sites / Locations
- Inselspital, University Hospital Bern, University of Bern
Arms of the Study
Arm 1
Experimental
Comparison result lymphoscintigraphy with ICG lymphography
The patient first receives a standard Tc-99m-based lymphoscintigraphy. The identified lymph nodes are not marked in the patients, so that the surgeons are not affected in lymph node identification during ICG and near infrared fluorescence imaging. The surgeon also has no access to lymphoscintigraphy images. Transcutaneous ICG lymphography is then performed by intradermal injection of ICG around the scar of the primary tumor excision and transcutaneous fluorescence evaluation with the Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD) and results are compared.