Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
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

Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-02-06

125

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

Sponsors

D

Dartmouth-Hitchcock Medical Center

Lead Sponsor

D

Dartmouth College

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 63 18 years of age
  • Histologic proof of non-melanoma skin cancer
  • Patients with different skin tones presenting with skin growth or lesions scheduled for resection
  • Willingness and ability to understand and comply with study procedures
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to study start
  • Lesions must measure between 5 mm and 3 cm in diameter
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Adults unable to provide informed consent
  • Known allergy to Ameluz
  • Photosensitivity or photodermatoses or similar conditions
  • Serious underlying medical conditions impairing treatment or compliance
  • Known hypersensitivity to porphyrins or any component of Ameluz including soya bean phosphatidylcholine
  • Females currently breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dartmouth Hitchcock

Lebanon, New Hampshire, United States, 03766

Actively Recruiting

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Research Team

D

Dylan L Parker, MD

CONTACT

S

Staci Shaw

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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