Recruiting

Tissue Oxygen ImagerAssessment 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

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07201376

Conditions

Non-Melanoma Skin Cancer (NMSC)

Benign Skin Growth

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ameluz 10% Topical Gel

Protoporphyrin IX

Study Details

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

Non-Melanoma Skin Cancer (NMSC)

Benign Skin Growth

Study ID

NCT07201376

Start date

Nov 14, 2025

Status verified date

Sep, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ameluz 10% Topical Gel

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

Protoporphyrin IX

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

Primary outcome measure

Detecting cutaneous malignant lesions using a non-invasive technique [ Time Frame: Six months after the first enrollment ]

Central Contacts and Locations

Central contacts

Dylan L Parker, MD

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

Staci Shaw

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

Locations

Dartmouth Hitchcock

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Dylan Parker, MD

6036532209 Dylan.J.Parker@Hitchcock.org

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Feb 6, 2026

Last verified

Sep, 2025

Keywords

Benign Skin Growth
Non-Melanoma Skin Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-02-06.