An observational study in Nevus and Dysplasia; Epithelial, sponsored by Orlucent, Inc. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Orlucent, Inc · Observational
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.
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.
47 studies on the registry are indexed under Nevus; 9 are open to participants now.
This study's enrollment of 300 is above the median of 145 across 28 observational studies indexed under Nevus.
Browse Nevus studies →Orlucent, Inc is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study a subject must meet all of the following criteria:
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.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Lesions that are consistent with
- Features of Keratosis and keratin plugs
Subjects with nevi that fit the inclusion criteria but are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with Nevi who will as part of their standard of care, will undergo biopsy.
Diagnostic Test: Skin Fluorescent Imaging
Application of reagents, then imaging and scoring
Also known as: SFI 003 Imaging
Establish the performance of SFI
Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.
Time frame: 1year
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
Time frame: 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
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2020 to primary completion in Jun 2023, 34 months.
Of 14 observational studies under Nevus, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 104. This study's 34 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orlucent, Inc