Pigmented LesionsNCT04566302
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
A study testing SECM Skin Imaging in people with Pigmented Lesions and Pigmented Skin Lesion, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles
- What is being tested?
- SECM Skin Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 22 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- 18 years of age or older
- Capable of giving informed consent
- Pigmented lesions (such as moles) present on the forearm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.
Read the 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.
- Conditions
- Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles, Skin Lesion
- Being tested
- SECM Skin Imaging
- Keywords
- SECM, Spectrally Encoded Confocal Microscopy, RCM, Reflectance Confocal Microscopy
- Medical subject headings
- Nevus, Pigmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SECM Skin ImagingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| SECM Skin Imaging | Experimental | 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. Receives: Device: SECM Skin Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Quality Skin Images Obtained From SECM Device
Measured: Approximate 30 minute study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start19 Jul 2021
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pigmented LesionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, M.D, PhD., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566302
- Sponsor's protocol ID
- 2019P001237
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2020
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
- ClinicalTrials.gov ID
- NCT04566302
- Acronym / sponsor ID
- 2019P001237
- Conditions
- Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles, Skin Lesion
- Keywords
- SECM, Spectrally Encoded Confocal Microscopy, RCM, Reflectance Confocal Microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SECM Skin Imaging | Experimental | Device: SECM Skin ImagingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults
- 18 years of age or older
- Capable of giving informed consent
- Pigmented lesions (such as moles) present on the forearm
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SECM Skin ImagingConsented 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 | Device | SECM Skin Imaging |
Primary outcome
Number of Participants With Quality Skin Images Obtained From SECM Device
Time frame: Approximate 30 minute study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pigmented Lesions
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
RecruitingObservational study
Dermoscopic and Histopathological Patterns of Pigmented Skin Lesions
All Pigmented Skin Tumors
Active, not recruitingObservational study
Study to Examine Lesions of the Skin Using Confocal Laser Microscopy
Benign Skin Tumor, Basal Cell Carcinoma
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
Active, not recruitingObservational study
Skin Imaging With Technologies in Development
Pigmented Skin Lesion of Uncertain Nature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Tearney, M.D, PhD. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SECM Skin Imaging in people with Pigmented Lesions and Pigmented Skin Lesion, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Quality Skin Images Obtained From SECM Device (time frame: Approximate 30 minute study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.