Benign Skin Growth, Non-Melanoma Skin Cancer (NMSC)
Conditions
Keywords
Benign Skin Growth, Non-Melanoma Skin Cancer
Brief summary
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).
Detailed description
The present study is an open-label, non-randomized, feasibility study aiming to evaluate the ability of a non-significant risk tissue oxygen imager based on protoporphyrin IX (PpIX) delayed fluorescence (DF) for differentiating benign from malignant skin lesions and assessing tumor margins during Mohs micrographic surgery.
Interventions
One-time topical application of 10% Ameluz gel for up to 1 hour
DEVICEProtoporphyrin IX
Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.
Sponsors
Dartmouth-Hitchcock Medical Center
Dartmouth College
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detecting cutaneous malignant lesions using a non-invasive technique | Six months after the first enrollment | Advancing our understanding of these cancers and developing effective strategies for diagnosis. The study will use aminolaevulinic acid (ALA) as a source of protoporphyrin IX (PpIX) to allow the detection of hypoxia signal. More specifically, the oxygen imager gathers the delayed fluorescence (DF) of PpIX, which intensity is inversely proportional to tissue mitochondrial oxygen content. This provides qualitative contrast on hypoxic regions with submillimeter spatial resolution. Transient hypoxia is a clear indicator of tumor tissue. We will validate the combination of hypoxia imaging with palpation as a non-invasive technique to detect cutaneous malignant lesions. |
Countries
United States
Contacts
CONTACTDylan L Parker, MD
CONTACTStaci Shaw
PRINCIPAL_INVESTIGATORMichael Chapman, MD
Dartmouth
Outcome results
None listed