Assessment of Skin Lesions Using a Tissue Oxygen Imager B... | NCT07201376

Studies
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

NCT07201376

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Non-Melanoma Skin Cancer (NMSC)
Benign Skin Growth

Interventions

Ameluz 10% Topical Gel
Protoporphyrin IX

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2025Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Sep 19, 2025

First Submission Date that Met QC Criteria

Sep 30, 2025

First Posted Date

Oct 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Name	Class
Dartmouth College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Six months after the first enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dylan L Parker, MD	Contact	603-653-2209		Dylan.J.Parker@Hitchcock.org
Staci Shaw	Contact	603-650-3693		Staci.L.Shaw@Hitchcock.org

Overall Officials

Name	Affiliation	Role
Michael Chapman, MD	Dartmouth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth Hitchcock	Recruiting	Lebanon	New Hampshire	03766	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to share identifiable data. All data will be owned and maintained by Dartmouth.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000622	Aminolevulinic Acid
D005782	Gels

ID	Term
D007982	Levulinic Acids
D007651	Keto Acids
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations