Pigmented Lesions, Pigmented Moles, Pigmented Skin Lesion, Skin Lesion
Conditions
Keywords
SECM, Spectrally Encoded Confocal Microscopy, RCM, Reflectance Confocal Microscopy
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.
Interventions
DEVICESECM 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
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Quality Skin Images Obtained From SECM Device | Approximate 30 minute study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | SECM Skin Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 36.875 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Number of Participants With Quality Skin Images Obtained From SECM Device
Time frame: Approximate 30 minute study
Population: 15 participants were imaged with both SECM device and dermatoscope.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SECM Skin Imaging | Number of Participants With Quality Skin Images Obtained From SECM Device | 15 Participants |