Non-Melanoma Skin Cancer (NMSC)PPIXNCT07201376
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
An observational study of Non-Melanoma Skin Cancer (NMSC) and Benign Skin Growth, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Melanoma Skin Cancer (NMSC), Benign Skin Growth
- What is being tested?
- Ameluz 10% Topical Gel and Protoporphyrin IX
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be enrolled from the Dermatology Clinic where the study is being performed.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766
Dylan Parker, MD, 6036532209, Dylan.J.Parker@Hitchcock.org
About this study
Official title: Tissue Oxygen Imager
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).
Read the 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.
- Being tested
- Ameluz 10% Topical Gel, Protoporphyrin IX
- Keywords
- Benign Skin Growth, Non-Melanoma Skin Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ameluz 10% Topical GelDrug
One-time topical application of 10% Ameluz gel for up to 1 hour
Protoporphyrin IXDevice
Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months after the first enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start14 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Melanoma Skin Cancer (NMSC)Studies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Michael S. Chapman, Dartmouth-Hitchcock Medical Center
- Investigators
- Michael Chapman, MD, Principal investigator, Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201376
- Sponsor's protocol ID
- STUDY02002181
- Acronym
- PPIX
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share identifiable data. All data will be owned and maintained by Dartmouth.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oxygen Imager
- ClinicalTrials.gov ID
- NCT07201376
- Acronym / sponsor ID
- PPIX / STUDY02002181
- Keywords
- Benign Skin Growth, Non-Melanoma Skin Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled from the Dermatology Clinic where the study is being performed.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ameluz 10% Topical GelOne-time topical application of 10% Ameluz gel for up to 1 hour | Drug | – |
| Protoporphyrin IXTissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device. | Device | – |
Primary outcome
Detecting cutaneous malignant lesions using a non-invasive technique
Time frame: Six months after the first enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. There is no plan to share identifiable data. All data will be owned and maintained by Dartmouth.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Chapman, MD principal investigator
Dartmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Melanoma Skin Cancer (NMSC) and Benign Skin Growth, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dylan L Parker, MD (603-653-2209, Dylan.J.Parker@Hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting cutaneous malignant lesions using a non-invasive technique (time frame: Six months after the first enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.