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NCT07201376Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
125 (estimated)
First submitted
19 Sept 2025
Start date
14 Nov 2025
Primary completion date
30 Nov 2026
Lead sponsor
Dartmouth-Hitchcock Medical Center
Diseases
Melanoma
NCT number
NCT07201376

What you commit to

  • Study type: Observational
  • Planned participants: 125
  • From 14 Nov 2025 to the primary completion date, 30 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Age

  • Patients who are \<18 years of age

Other

  • Adults who are unable to provide informed consent.
  • Females who are currently breast-feeding

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dartmouth Hitchcock
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.