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Assessing Skin Lesions with a Tissue Oxygen Imager

This study is looking at a new way to tell the difference between non-melanoma skin cancer (NMSC) and benign (non-cancerous) skin growths. Researchers will use a special device called a tissue oxygen imager, which uses Protoporphyrin IX (PIX), after a one-time application of Ameluz 10% Topical Gel to the skin. The goal is to see how well this imaging technique can identify cancerous lesions. You might be able to join if you are an adult aged 18 or older with a confirmed diagnosis of non-melanoma skin cancer and are scheduled for surgery to remove the growth. The study aims to enroll 125 participants, but the current recruitment status is unclear.

Study design
This is an open-label, non-randomized feasibility study. It aims to enroll 125 participants.
What's involved
Participants will have a one-time application of Ameluz 10% Topical Gel for up to one hour, followed by local imaging.
Compensation
Not stated in the trial record.
Follow-up
The study will measure its primary goal six months after the first participant enrolls.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07201376

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

Recruiting
Not specifiedAges 18+Observational
Dartmouth-Hitchcock Medical Center
~125 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Ameluz 10% Topical GelProtoporphyrin IX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detecting cutaneous malignant lesions using a non-invasive technique
Measured over Six months after the first enrollment

Conditions

Non-Melanoma Skin Cancer (NMSC)
Benign Skin Growth

Explore related trials

Benign Skin GrowthSkin Carcinoma

NCT07201376

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dartmouth Hitchcock

    Lebanon, New Hampshirestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael Chapman, MD · PRINCIPAL_INVESTIGATOR · Dartmouth

Who to contact

Dylan L Parker, MD
[email protected]
603-653-2209
Email the study team

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Detecting cutaneous malignant lesions using a non-invasive techniqueSix months after the first enrollment

    Advancing our understanding of these cancers and developing effective strategies for diagnosis. The study will use aminolaevulinic acid (ALA) as a source of protoporphyrin IX (PpIX) to allow the detection of hypoxia signal. More specifically, the oxygen imager gathers the delayed fluorescence (DF) of PpIX, which intensity is inversely proportional to tissue mitochondrial oxygen content. This provides qualitative contrast on hypoxic regions with submillimeter spatial resolution. Transient hypoxia is a clear indicator of tumor tissue. We will validate the combination of hypoxia imaging with palpation as a non-invasive technique to detect cutaneous malignant lesions.