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

Tissue Oxygen Imager

This project will test a PpIX-based tissue oxygen imager to see if it can tell benign skin growths from non-melanoma skin cancers in adults who have lesions scheduled for removal.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dartmouth-Hitchcock Medical Center (other)
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT07201376 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with skin growths or lesions (5 mm–3 cm) suspected or proven to be non-melanoma skin cancer and who are able to consent and attend the Dartmouth-Hitchcock site are ideal candidates.

Not a fit: People under 18, those with known allergy to Ameluz, photosensitivity or photodermatoses, or those with serious medical conditions that prevent participation or with lesions outside the 5 mm–3 cm range are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the imager could help clinicians noninvasively distinguish benign growths from non-melanoma skin cancers and better define surgical margins.

How similar studies have performed: PpIX-based fluorescence methods have shown promise for detecting skin cancers and guiding margins, but the specific delayed-fluorescence tissue oxygen imaging approach used here is relatively novel and not yet widely validated.

Eligibility criteria

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 this trial is running

Lebanon, New Hampshire

• Dartmouth Hitchcock — Lebanon, New Hampshire, United States (RECRUITING)

Study contacts

• Principal investigator: Michael Chapman, MD — Dartmouth
• Study coordinator: Dylan L Parker, MD

Conditions: Non-Melanoma Skin Cancer, Benign Skin Growth