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

NCT ID: NCT07201376

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-11-30

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.

Conditions

Non-Melanoma Skin Cancer (NMSC); Benign Skin Growth

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Ameluz 10% Topical Gel

One-time topical application of 10% Ameluz gel for up to 1 hour

Intervention Type: DRUG

Protoporphyrin IX

Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael S. Chapman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Chapman, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth

Central Contacts

Dylan L Parker, MD

Role: CONTACT

Dylan.J.Parker@Hitchcock.org

603-653-2209

Staci Shaw

Role: CONTACT

Staci.L.Shaw@Hitchcock.org

603-650-3693

Other Identifiers

STUDY02002181

Identifier Type: -

Identifier Source: org_study_id