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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Skin Lesion; Pigmented Lesions; Pigmented Skin Lesion; Pigmented Moles
• Intervention / Treatment: Device: SECM Skin Imaging

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: SECM Skin Imaging; Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of SECM device to image skin and skin diseases	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.	Imaging data is collected during the procedure, and analyzed within 1 year of collection.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Guillermo Tearney, M.D, PhD., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: SECM; Reflectance Confocal Microscopy; Spectrally Encoded Confocal Microscopy; RCM
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus; Nevus, Pigmented; Pigmentation Disorders
• Other Study ID Numbers: 2019P001237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No