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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

Recruitingn/aAges 18 Years - anyAllDartmouth-Hitchcock Medical Center
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults โ‰ฅ 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. Exclusion Criteria: * 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. * 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. * Females who are currently breast-feeding
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What it tests

  • Ameluz 10% Topical Gel
  • Protoporphyrin IX
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Where

1 site
Dartmouth Hitchcock
Lebanon, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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