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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ameluz 10% Topical Gel, Protoporphyrin IX.
- Who it may be relevant to
- Registry conditions: Non-Melanoma Skin Cancer (NMSC), Benign Skin Growth. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tissue Oxygen Imager
Overview
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).
Detailed 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.
Interventions
- Drug Ameluz 10% Topical Gel
One-time topical application of 10% Ameluz gel for up to 1 hour - Device Protoporphyrin IX
Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.
Primary outcome measures
- Detecting cutaneous malignant lesions using a non-invasive technique [Time frame: Six months after the first enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Dartmouth Hitchcock — Lebanon
Identifiers
NCT: NCT07201376 · STUDY02002181