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

NCT ID: NCT02009085

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

Skin Lesions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Individuals undergoing skin excision.

Skin lesions are under suspicion for skin cancer.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clalit Health Services

OTHER

Sponsor Role: collaborator

Orlucent, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehuda Ullmann, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Other Identifiers

KH 2012

Identifier Type: -

Identifier Source: org_study_id