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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

RecruitingObservational studyHealthy volunteers welcome

Tissue Oxygen Imager

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Dartmouth-Hitchcock Medical Center · Participants: 125 · Started: Nov 14, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07201376

Locations in the U.S.

New HampshireDartmouth Hitchcock, Lebanon

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.