NCT07201376 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dartmouth-Hitchcock Medical Center |
| Condition | Non-Melanoma Skin Cancer (NMSC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2025-11-14 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Michael Chapman, MD
PRINCIPAL INVESTIGATOR
Dartmouth
Frequently Asked Questions
Who can join the NCT07201376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Melanoma Skin Cancer (NMSC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07201376 currently recruiting?
Yes, NCT07201376 is actively recruiting participants. Contact the research team at Dylan.J.Parker@Hitchcock.org for enrollment information.
Where is the NCT07201376 trial being conducted?
This trial is being conducted at Lebanon, United States.
Who is sponsoring the NCT07201376 clinical trial?
NCT07201376 is sponsored by Dartmouth-Hitchcock Medical Center. The principal investigator is Michael Chapman, MD at Dartmouth. The trial plans to enroll 125 participants.
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