Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases

Inclusion criteria

• 18 years of age or older
• Histologically confirmed diagnosis of melanoma at MSKCC
• Have one of the following disease histories:
• Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma, oral cavity squamous cell carcinoma, and squamous cell carcinoma of the skin patients in whom SLN mapping is indicated

• Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas
• Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
• Newly diagnosed patients with previous excisional biopsy.
• At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
• At the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl.
• At the discretion of the physician or surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
• For melanoma patients, if patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.
• All patients of childbearing and child-creating age must be using an acceptable form of birth control
• Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion criteria

• Known pregnancy or breast-feeding.
• Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.