RecruitingNCT07201376

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

Tissue Oxygen Imager


Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

125 participants

Start Date

Nov 14, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study is testing a new imaging technique that uses a special light-sensitive chemical (protoporphyrin IX) and a tissue oxygen imaging device to better visualize and assess non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) before surgical removal. **You may be eligible if...** - You are 18 or older - You have been confirmed to have non-melanoma skin cancer by a tissue biopsy - Your skin lesion measures between 5 mm and 3 cm - You are scheduled for surgical removal of the lesion - If you are a woman of childbearing age, you have a negative pregnancy test within 7 days before the study **You may NOT be eligible if...** - You are under 18 years old - You are unable to understand or follow study procedures - You are pregnant or breastfeeding - You have a known allergy to the topical medication used in the imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Dartmouth Hitchcock

Lebanon, New Hampshire, United States

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NCT07201376


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