NevusNCT04368247
Skin Fluorescent Imaging (SFI) System in Patients With Nevi
An observational study of Nevus and Dysplasia; Epithelial, run by Orlucent, Inc at 4 sites in United States.
Trial summary
The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nevus, Dysplasia; Epithelial
- What is being tested?
- Skin Fluorescent Imaging
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Aug 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Subjects who present with suspicious nevus/nevi and who require a Standard of Care (SOC) biopsy of the atypical nevi will be able to participate in the study.
Who may be able to join
- In order to be eligible to participate in this study a subject must meet all of the following criteria:
- Provide a signed and dated informed consent form
- Age ≥ 18 years old
- Subjects must present with suspicious atypical nevi scheduled for a biopsy*
- Nevi with at least 1 cm of skin surrounding the mole
- Nevi must be accessible to the SFI imaging device
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- Excisional or a tangential excision with a dept of 1 to 2 mm biopsy will be performed for the mole tested within 21 days of testing.
- Nevi with clinically atypical features
- Only 1 mole per eligible subject will be SFI tested in this study. NOTE: a subset of patients (~10%) with benign nevi (by clinical observation) who wish to have nevi removed for cosmetic reasons will be enrolled as negative controls.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subjects who are younger than 18 years old
- Lesions that are consistent with
- Features of Keratosis and keratin plugs
- Basal Cell Carcinoma
- Squamous Cell Carcinoma
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- Challenging anatomical location (e.g., body cervices)
- Subjects with nevi that fit the inclusion criteria but are:
- Less than 1 cm from the eyes
- On the palms of the hands or soles of the feet
- Associated with scar tissue
- Mucosal lesions
- Ulcerated lesions / breached skin
- Lesions with some clinical certainty of being melanomas (large, dark, etc.)
- Any nevi with ink marking including tattoos, on or adjacent to the nevi
- Lesions treated with local anesthesia such as lidocaine prior to enrollment
- Lesions larger than 20 mm or too large to allow imaging
- Subject is known to be pregnant
- Subject who is mentally or physically unable to comply with all aspects of the study
- Subject who is undergoing systemic cancer treatment within 6 months of SFI testing
- Subject with hypersensitivity to any of the SFI reagents
- Subjects with known sensitivity to fluorescent dyes
- Any subject who has previously participated (testing to biopsy) in SFI 003
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
Quest Dermatology Research
Northridge, California, 91324
University of Utah
Salt Lake City, Utah, 84112
Solano Dermatology Associates
Vallejo, California, 94590
About this study
The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.
Read the detailed description
The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.
- Conditions
- Nevus, Dysplasia; Epithelial
- Being tested
- Skin Fluorescent Imaging
- Keywords
- Nevus, Atypical Nevi, Mole, Skin Imaging
- Medical subject headings
- Nevus, Carcinoma in Situ, Dysplastic Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Fluorescent ImagingDiagnostic test
Also called SFI 003 Imaging
Application of reagents, then imaging and scoring
| Study group | Role | What they receive |
|---|---|---|
| Nevi undergoing biopsy per SOC | Subjects with Nevi who will as part of their standard of care, will undergo biopsy. Receives: Diagnostic Test: Skin Fluorescent Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the performance of SFI
Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.
Measured: 1year
Secondary outcomes (2)
To compare SFI to clinical diagnosis.
Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist
Measured: 1 year
To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.
Adverse events will be collected to ensure overall safety of reagents and imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start10 Aug 2020
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevusStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cathy Shachaf, PhD, Study director, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368247
- Sponsor's protocol ID
- SFI 003
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Fluorescent Imaging (SFI) System in Patients With Nevi
- ClinicalTrials.gov ID
- NCT04368247
- Acronym / sponsor ID
- SFI 003
- Conditions
- Nevus, Dysplasia; Epithelial
- Keywords
- Nevus, Atypical Nevi, Mole, Skin Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 29 Apr 2020 (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 Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.
Detailed description
The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevi undergoing biopsy per SOC | – | Diagnostic Test: Skin Fluorescent ImagingSubjects with Nevi who will as part of their standard of care, will undergo biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who present with suspicious nevus/nevi and who require a Standard of Care (SOC) biopsy of the atypical nevi will be able to participate in the study.
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study a subject must meet all of the following criteria:
- Provide a signed and dated informed consent form
- Age ≥ 18 years old
- Subjects must present with suspicious atypical nevi scheduled for a biopsy*
- Nevi with at least 1 cm of skin surrounding the mole
Key exclusion criteria (23 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subjects who are younger than 18 years old
- Lesions that are consistent with
- Subjects with nevi that fit the inclusion criteria but are:
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 |
|---|---|---|
| Skin Fluorescent ImagingAlso: SFI 003 ImagingApplication of reagents, then imaging and scoring | Diagnostic test | Nevi undergoing biopsy per SOC |
Primary outcome
Establish the performance of SFI
Time frame: 1year
Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.
2 secondary outcomes
To compare SFI to clinical diagnosis.
Time frame: 1 year
To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Cathy Shachaf, PhD study director
President
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nevus and Dysplasia; Epithelial, run by Orlucent, Inc at 4 sites 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 9 inclusion and 23 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: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the performance of SFI (time frame: 1year). 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 7 Aug 2025.