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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

ConditionsNon-Melanoma Skin Cancer (NMSC)Benign Skin Growth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Participants will be enrolled from the Dermatology Clinic where the study is being performed.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Ameluz 10% Topical Gel

    Drug

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

  • Protoporphyrin IX

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Detecting cutaneous malignant lesions using a non-invasive technique

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.

Time frame
Six months after the first enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Dartmouth College

Collaborator

Source ClinicalTrials.gov
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