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

Primary Purpose

Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SECM Skin Imaging
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pigmented Lesions focused on measuring SECM, Spectrally Encoded Confocal Microscopy, RCM, Reflectance Confocal Microscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SECM Skin Imaging

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
July 25, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04566302
Brief Title
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Official Title
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles, Skin Lesion
Keywords
SECM, Spectrally Encoded Confocal Microscopy, RCM, Reflectance Confocal Microscopy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SECM Skin Imaging
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
SECM Skin Imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Ability of SECM device to image skin and skin diseases
Description
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.
Time Frame
Imaging data is collected during the procedure, and analyzed within 1 year of collection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, M.D, PhD.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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