Pilot Study to Determine Feasibility of Benign and Malign... | NCT02009085

Studies
Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.

NCT02009085

Sponsor

Orlucent, Inc

Status

Completed

Last Update Posted

Feb 19, 2018Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Skin Lesions

Interventions

Not provided

Countries

Not provided

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

Jun 2013

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Nov 25, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 11, 2013Estimated

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

Feb 14, 2018

Last Update Posted Date

Feb 19, 2018Actual

Name	Class
Clalit Health Services	OTHER

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

In this study a fluorescent contrast dye is applied to a suspicious skin lesion.

Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.

Detailed Description

Images acquired in the study are used for the development of a software analysis program.

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

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Individuals undergoing skin excision.		Skin lesions are under suspicion for skin cancer.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between imaging and pathology.	Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated. No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.	No long term follow up is necessary.

Secondary Outcomes

Measure	Description	Time Frame
Acute response	The acute dermal response to the imaging procedure is evaluated.	up to 1 day

Other Outcomes

Measure	Description	Time Frame
None specified.	no other outcome is specified in the .	0

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over the age of 18
Individual is scheduled for a skin biopsy in toto
The lesion is pigmented or non pigmented
Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
The lesion is accessible to the imaging device

Exclusion Criteria:

The patient has sensitive skin and easily breaks out in rash
The lesion is within 1 cm of the eye
The lesion is on mucosal surfaces (e.g., lips, genitals)
Pregnant females
Taking medications that pigments the skin

Accepts Healthy Volunteers

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

Patients above 18 years scheduled for a skin biopsy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yehuda Ullmann, MD	Rambam Health Care Campus	Principal Investigator

Locations

Not provided