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

Not Applicable

• Conditions: Pigmented Lesions; Pigmented Moles; Skin Lesion; Pigmented Skin Lesion
• Interventions: Device: SECM Skin Imaging

• Registration Number: NCT04566302
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2021-07-19
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SECM Skin Imaging	SECM Skin Imaging	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.

Primary Outcome Measures

Name	Time	Method
Ability of SECM device to image skin and skin diseases	Imaging data is collected during the procedure, and analyzed within 1 year of collection.	The quality, resolution and depth of the images will be reviewed by the PI. This is a qualitative analysis to determine the feasibility of the device, the parameters mentioned will be compared to correlative data obtained from the dermatoscope control. Unit measurements are not available.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States