Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Nevus, Pigmented

Nevus

Melanoma

Nevi and Melanomas

Neoplasms by Histologic Type

Subjects with Nevi who will as part of their standard of care, will undergo biopsy.

Application of reagents, then imaging and scoring

Skin Fluorescent Imaging

BRANDI DUNN

Cathy Shachaf

Anchal Dhawan

Sunil Dhawan, MD

Lawrence Osman, MD

Serena Mraz, MD

Doug Grossman, MD

Douglas Grossman, MD

Cathy Shachaf, PhD

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.

If the Site specific pathology lab will not allow the sponsor to make a digital image of the original slide, then the Sponsor is asking that a duplicate slide be provided for digital scanning. Once scanning is complete these additional slides may not be returned to the site.

Skin Fluorescent Imaging (SFI) System in Patients With Nevi

Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.

Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist

Adverse events will be collected to ensure overall safety of reagents and imaging

Orlucent, Inc

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Subject with suspicious Nevi undergoing biopsy per SOC

Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy

Diagnostic Test

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. SFI analyzes the topical staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. The system provides a biometric score corresponding to the dye staining, a structural score, and a composite SFI score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.

Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)

Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)

To identify histological features that correlate with the imaging features captured using SFI

Wounds and Injuries

Infections

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Scleroderma, Systemic

Scleroderma, Diffuse

Keratosis, Actinic

Keratosis

Burns

Carcinoma, Basal Cell

Sarcoma

Keratosis, Seborrheic

Histiocytoma

Sarcoma, Kaposi

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Carcinoma, Merkel Cell

Histiocytoma, Benign Fibrous

Neoplasms, Glandular and Epithelial

Neoplasms, Connective and Soft Tissue

Neoplasms, Basal Cell

Communicable Diseases

Herpesviridae Infections

Virus Diseases

DNA Virus Infections

Neoplasms, Vascular Tissue

Polyomavirus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Adenocarcinoma

Congenital Abnormalities

Skin Abnormalities

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Systemic Scleroderma

Soft Tissue Sarcoma

Kaposi Sarcoma

Merkel Cell Carcinoma

Optical Biopsy imaging

John S Nelson, M.D,Ph.D

This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

Optical Biopsy of Human Skin in Conjunction With Laser Treatment

Beckman Laser Institute University of California Irvine

University of California, Irvine

J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skin Fluorescent Imaging (SFI) System in Patients With Nevi	NCT04368247	Nevus Dysplasia; Epit...	Skin Fluorescen...	18 Years -	Orlucent, Inc
Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)	NCT03535077	Skin Lesion Melanoma (Skin) Mole	Diagnostic Test	21 Years -	Orlucent, Inc
Optical Biopsy of Human Skin in Conjunction With Laser Treatment	NCT00540566	Malignant Melan... Merkel Cell Car... Basal Cell Carc... Squamous Cell C... Atypical Nevi Congenital Nevi Seborrheic Kera... Paget's Disease Dermatofibroma Kaposi's Sarcom... Port Wine Stain Hemangioma Tattoos Scleroderma Burns	Optical Biopsy ...	18 Years - 75 Years	University of California, Irvine

Spots Global Cancer Trial Database for atypical nevi