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
About this study
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).
- Condition
- Non-Melanoma Skin Cancer (NMSC), Benign Skin Growth
- Tested
- Ameluz 10% Topical Gel, Protoporphyrin IX
- Sponsor
- Dartmouth-Hitchcock Medical Center
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Non-Melanoma Skin Cancer (NMSC), Benign Skin Growth
- 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.
Exclusion 7
- 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
Where
1 site, 1 recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Contact
-
Dylan L Parker, MD
603-653-2209 Dylan.J.Parker@Hitchcock.org
-
Staci Shaw
603-650-3693 Staci.L.Shaw@Hitchcock.org
Potential match only. Final eligibility is determined by the study team.