Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    Menkes Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03535077
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Orlucent, Inc

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

Condition or disease Intervention/treatment
Skin Lesion Melanoma (Skin) Mole Other: Diagnostic Test

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : February 28, 2019


Group/Cohort Intervention/treatment
Suspicious Nevi undergoing biopsy
Subject with suspicious Nevi undergoing biopsy per SOC
Other: Diagnostic Test
Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy
Other Name: SFI 001 Imaging




Primary Outcome Measures :
  1. Correlation [ Time Frame: 1 day ]
    To identify histological features that correlate with the imaging features captured using SFI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will enroll subjects being evaluated for suspicious moles/nevi and who will be scheduled to undergo a biopsy of the mole/nevus as part of the physicians standard plan of care.
Criteria

Inclusion Criteria:

  1. Subjects with a pigmented skin lesion recommended for a skin biopsy.
  2. A lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
  3. At least 21 years old.
  4. Written, signed, and dated informed consent
  5. Scheduled for a primary excision/biopsy as part of the clinics SOC.

Exclusion Criteria:

  1. Lesion is less than 1 centimeter from the eyes.
  2. Lesion is on the palms of the hands or soles of the feet.
  3. Mucosal lesion.
  4. Ulcerated lesion.
  5. Subject is pregnant or planning to become pregnant during the study period.
  6. Patients who are mentally or physically unable to comply with all aspects of the study.
  7. Any subject undergoing chemotherapy.
  8. Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535077


Contacts
Layout table for location contacts
Contact: Project Manager 2107714024 brandi.dunn@orlucent.com

Locations
Layout table for location information
United States, California
Divya Railan, Md, Faad Recruiting
Menlo Park, California, United States, 94025
Contact: Divya Railan, MD    650-322-1100    info@railanmd.com   
Principal Investigator: Divya Railan, MD         
The Menkes Clinic & Surgery Center Not yet recruiting
Mountain View, California, United States, 94040
Contact: Meredith Masri    650-962-4609    meredith@menkesclinic.com   
Principal Investigator: Andrew B Menkes, MD         
Sub-Investigator: Lillian Soohoo, MD         
Sub-Investigator: Krystle Wang, MD         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Orlucent, Inc

Layout table for additonal information
Responsible Party: Orlucent, Inc
ClinicalTrials.gov Identifier: NCT03535077     History of Changes
Other Study ID Numbers: SFI 001
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Orlucent, Inc:
Melanoma
Nevus
Mole
Atypical Nevi

Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas