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

Skin Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009085
• Other study ID #: KH 2012
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: February 14, 2018
• Start date: June 2013
• Est. completion date: June 2017

Study information

• Verified date: February 2018
• Source: Orlucent, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Lesions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Orlucent, Inc	Clalit Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	None specified.	no other outcome is specified in the .	0
Primary	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	Acute response	The acute dermal response to the imaging procedure is evaluated.	up to 1 day