Non-invasive Melanoma Assessment Using a Topical Fluoresc... | NCT02056522

Studies
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

NCT02056522

Sponsor

Orlucent, Inc

Status

Completed

Last Update Posted

Nov 18, 2020Actual

Enrollment

357Actual

Phase

Not provided

Conditions

Skin Lesions

Interventions

Not provided

Countries

Israel

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Dec 15, 2013

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 6, 2014Estimated

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

Nov 17, 2020

Last Update Posted Date

Nov 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 use of MDS to access the presence of melanoma in the skin.

Detailed Description

A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

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

357Actual

Label	Type	Description	Intervention Names
Suspicious skin lesions.		No intervention is administered.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To validate the performance of MDS		28 days

Secondary Outcomes

Measure	Description	Time Frame
To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.		28 days

Other Outcomes

Measure	Description	Time Frame
To further establish the safety of the MDS.		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
Male and female ≥ 21 years old.
Subject is capable of giving written informed consent.
Primary excision.

Exclusion Criteria:

The lesion is less than 1 cm from the eyes.
The lesion is on the palms of hands or soles of the feet.
Mucosal lesion.
Pregnant females.
Low study procedure compliance.
Patients who are mentally or physically unable to comply with all aspects of the study.
Undergoing chemotherapy.
Minor or legally incompetent and not able to sign the consent form.
Patient previously tested by MDS and was diagnosed with melanoma during the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

97 Years

Standard Ages

AdultOlder Adult

Study Population

Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shokrey Kassis, MA	Head of Plastic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clalit Health Services		Kiryat Bialik			Israel
Ziv Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D012878	Skin Neoplasms

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided