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

Pilot Study to Asses the Identification of Melanoma in Skin Lesions.

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.

Study Overview

• Status: Completed
• Conditions: Skin Lesions

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 126

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients above 18 years scheduled for a skin biopsy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Individuals undergoing skin excision.; Skin lesions are under suspicion for skin cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description
None specified.	no other outcome is specified in the .

Collaborators and Investigators

• Sponsor: Orlucent, Inc
• Collaborators: Clalit Health Services
• Investigators: Principal Investigator: Yehuda Ullmann, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KH 2012