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

Skin Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04566302
• Other study ID #: 2019P001237
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: April 2025

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nevus, Pigmented
• Pigmentation Disorders
• Pigmented Lesions
• Pigmented Moles
• Pigmented Skin Lesion
• Skin Lesion

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.