Tissue Oxygen Imager
Dartmouth-Hitchcock Medical Center
Summary
The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 pregnanc…
Interventions
- DrugAmeluz 10% Topical Gel
One-time topical application of 10% Ameluz gel for up to 1 hour
- DeviceProtoporphyrin IX
Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.
Location
- Dartmouth HitchcockLebanon, New Hampshire