Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

Mass General Brigham

Status: Completed

Conditions: Pigmented Moles; Pigmented Lesions; Skin Lesion; Pigmented Skin Lesion

Treatments: Device: SECM Skin Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04566302

2019P001237

Details and patient eligibility

About

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

Full description

SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults
• 18 years of age or older
• Capable of giving informed consent
• Pigmented lesions (such as moles) present on the forearm

Exclusion criteria

• Unable to provide consent
• Open cuts/sores on the skin, skin infection, or any contagious skin condition
• Pregnant women (according to subject)
• Employees under the direct supervision of the investigator

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

SECM Skin Imaging

Experimental group

Description:

The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.

Treatment:

Device: SECM Skin Imaging