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

Tissue Oxygen Imager

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-14
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2025-10-01
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study