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

NCT07201376 | Recruiting FDA Drug

• 1 other identifier: STUDY02002181
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Benign Skin Growth; Non-Melanoma Skin Cancer (NMSC)

Keywords

Benign Skin Growth; Non-Melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Detecting cutaneous malignant lesions using a non-invasive technique

  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.

  Six months after the first enrollment

Interventions

Ameluz 10% Topical Gel DRUG

One-time topical application of 10% Ameluz gel for up to 1 hour

Protoporphyrin IX DEVICE

Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from the Dermatology Clinic where the study is being performed.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth College: collaborator
• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock

Lebanon, New Hampshire, 03766, United States

RECRUITING

MeSH Terms

Interventions

Aminolevulinic Acid; Gels

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael Chapman, MD

  Dartmouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dylan L Parker, MD

CONTACT

603-653-2209; Dylan.J.Parker@Hitchcock.org

Staci Shaw

CONTACT

603-650-3693; Staci.L.Shaw@Hitchcock.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 1, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)