Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluores… (NCT07201376) | Clinical Trial Compass
RecruitingNot Applicable
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
United States125 participantsStarted 2025-11-14
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Detecting cutaneous malignant lesions using a non-invasive technique