PpIX fluorescence tissue oxygen imaging to tell benign from non-melanoma skin lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-randomized feasibility project applies a one-time topical Ameluz (to generate PpIX) followed by delayed fluorescence tissue oxygen imaging of skin lesions. Images from the PpIX DF imager will be compared with surgical and histologic findings, including during Mohs micrographic surgery, to determine whether benign and malignant lesions can be differentiated and margins delineated. Adults with lesions 5 mm to 3 cm and with a clinical or histologic concern for non-melanoma skin cancer are eligible. The procedure is non-significant risk and performed at a single center with participants of varied skin tones included.

Why it matters

Who can join: the full rules

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

Where it's running

• Dartmouth Hitchcock
  Lebanon, New Hampshire, United States Recruiting

Study contacts

• Principal investigator: Michael Chapman, MD — Dartmouth
• Study coordinator: Dylan L Parker, MD
• Email: Dylan.J.Parker@Hitchcock.org
• Phone: 603-653-2209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.