Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically

The present study is an open-label, non-randomized, feasibility study aiming to evaluate the ability of a non-significant risk tissue oxygen imager based on protoporphyrin IX (PpIX) delayed fluorescence (DF) for differentiating benign from malignant skin lesions and assessing tumor margins during Mohs micrographic surgery.

Inclusion criteria

• Adults ≥ 18 years of age.
• Histologic proof of non-melanoma skin cancer. Patients with different skin tones based on the Fitzpatrick Scale, who present with skin growth or lesions and are scheduled for resection.
• As determined by the enrolling physician or study team member, the patient must have the willingness and ability to understand and comply with study procedures.
• Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of study.
• Lesions must measure between 5 mm and 3 cm in diameter.

Exclusion criteria

• Patients who are <18 years of age
• Adults who are unable to provide informed consent.
• Known allergy to Ameluz
• Photosensitivity or photodermatoses or similar conditions.
• Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol, in the opinion of the investigator
• Known hypersensitivity to porphyrins or to any component of Ameluz, including soya bean phosphatidylcholine.
• Females who are currently breast-feeding