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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ameluz 10% Topical Gel
  • Protoporphyrin IX

Treatment groups

No treatment groups listed

Sponsors and collaborators