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Imaging device to tell benign skin growths from skin cancer

Tests an oxygen imaging device after Ameluz gel in adults with skin lesions.

Key facts

Who runs it
Dartmouth-Hitchcock Medical Center
Where
Lebanon, United StatesSee the site
Trial code
Registry 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
Status
Recruiting
People taking part
125 people, planned
Started
14 Nov 2025
Expected to end
Nov 2027
Type of study
Observational
Treatments tested
  • Ameluz 10% Topical Gel
  • Protoporphyrin IX
Record updated
6 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a skin growth or lesion who are scheduled for surgical removal. It tests an imager that tells harmless skin growths from non-melanoma skin cancer.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Skin growth or lesion, scheduled for resection. Lesions must measure between 5 mm and 3 cm (1.2 in) in diameter.

Main reasons for not taking part

  • Known allergy to Ameluz, or hypersensitivity to porphyrins or to any part of Ameluz, including soya bean phosphatidylcholine
  • Photosensitivity or photodermatoses or similar conditions
  • A serious medical condition that would impair receiving or tolerating the planned treatment or following the study
  • Currently breast-feeding
  • Unable to give informed consent

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Patients who are <18 years of age
  • Adults who are unable to provide informed consent
  • Females who are currently breast-feeding

Where in United States

  • Dartmouth HitchcockLebanon, United StatesContact: Dylan Parker, MDTaking people

About the trial

What the trial wants to find out

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).

Treatments tested

  • Ameluz 10% Topical Gel
  • Protoporphyrin IX

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Tissue Oxygen Imager
Plain-language title
Imaging device to tell benign skin growths from skin cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 February 2026