Comparison Imaging System Between Spatially Modulated Qua... | NCT02473874

Studies
Comparison Imaging System Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy

NCT02473874

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Nov 1, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Melanocytic Nevus

Interventions

Skin Spect dermoscope
Spatially modulated quantitative

Countries

United States

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not NIH defined clinical trial study.

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jan 2020Actual

Completion Date

Jan 2020Actual

First Submitted Date

Jun 5, 2015

First Submission Date that Met QC Criteria

Jun 12, 2015

First Posted Date

Jun 17, 2015Estimated

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

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Kristen Kelly, M.D., Professor of Dermatology and Surgery, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to obtain skin spectroscopic data from two imaging systems.

Comparison groups:

Skin Spect dermoscope
Spatially modulated quantitative spectrometer

Detailed Description

The researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements.

Skin Spect can measure larger area of skin, whereas Spatially modulated quantitative spectrometer is a point-based measurement.Therefore, larger nevi will require multiple Spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger Skin Spect measurements. Only sub-regions of the image data from Skin Spect that match the locations Spatially modulated quantitative spectrometer acquired data will be used in this correlation study.

This researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Skin Spect dermoscope		Skin mole	Device: Skin Spect dermoscope
Spatially modulated quantitative		Skin mole	Device: Spatially modulated quantitative

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin Spect dermoscope	Device	Skin imaging	Skin Spect dermoscope
Spatially modulated quantitative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in human skin structure	Comparison Imaging Changes in human skin structure Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy	up to 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Skin lesion a mole located on flat surface of the body

Exclusion Criteria:

Mole located on complex surface
Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects will be recruited from an outpatient population of subjects at Beckman Laser Medical Clinic, University of California, Irvine.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristen Kelly, MD	Beckman Laser Institute, UCI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute		Irvine	California	92612	United States

Condition Browse Module

MeSH Terms

ID	Term
D009508	Nevus, Pigmented

Ancestor Terms

ID	Term
D009506	Nevus
D018326	Nevi and Melanomas
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided