SECM Skin Imaging for Skin Diseases

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Open cuts, Skin infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for taking detailed pictures of the skin using Spectrally Encoded Confocal Microscopy (SECM). The goal is to evaluate how well this tool examines skin issues, such as moles, compared to existing methods. The trial seeks healthy adults with moles on their forearm who can provide informed consent. Participants will have their moles examined first with a common tool called a dermatoscope and then with the SECM device. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance skin imaging techniques.

Do I need to stop taking my current medications for the SECM Skin Imaging trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the study team for guidance.

What prior data suggests that SECM Skin Imaging is safe for skin diseases?

Research has shown that Spectrally Encoded Confocal Microscopy (SECM) is being tested for capturing detailed images of human skin and skin conditions. It functions similarly to other approved skin imaging devices. Studies have found that SECM successfully captures skin images using specific light wavelengths, indicating its practicality. No safety issues have been reported. Since SECM is in the "Not Applicable" phase, the focus remains on its imaging capabilities rather than treatment, typically suggesting minimal safety concerns. This makes SECM a promising option for those interested in advanced skin imaging without the risks associated with drug trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SECM Skin Imaging because it offers a new way to visualize skin lesions with potentially greater precision. Unlike traditional methods, such as visual observation with a dermatoscope, SECM provides a closer look at skin structures. This could lead to more accurate assessments of skin conditions like moles. The hope is that SECM will enhance diagnostic accuracy and improve treatment decisions, making it a promising development in dermatology.

What evidence suggests that SECM skin imaging is effective for skin diseases?

Research has shown that Spectrally Encoded Confocal Microscopy (SECM) can capture detailed images of human skin in real time. This imaging method resembles other approved devices that have accurately identified skin conditions like melanoma and basal cell carcinoma. SECM quickly delivers clear skin images, enabling doctors to observe cellular-level changes. This capability may aid in earlier detection of skin problems. The trial will evaluate SECM's effectiveness compared to other methods. ^{1 6 7 8 9}

Who Is on the Research Team?

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who can give informed consent and have pigmented skin lesions, like moles, on their forearm. It's not open to those unable to consent, with open cuts/sores or infections on the skin, pregnant women, or employees supervised by the investigator.

Inclusion Criteria

I understand the study and can agree to participate.

I have moles on my forearm.

Exclusion Criteria

Pregnant women (according to subject)

I do not have open cuts, skin infections, or contagious skin conditions.

I am unable to give my consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo imaging of skin lesions using a dermatoscope and SECM device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SECM Skin Imaging

Trial Overview The study is testing a new way of looking at human skin using Spectrally Encoded Confocal Microscopy (SECM). The goal is to see how well SECM can image the skin and identify any diseases present in it.

How Is the Trial Designed?

Group I: SECM Skin Imaging Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04566302

Pilot Study of Imaging Human Skin With High-Speed ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S001346862300871X

In-situ monitoring of signal transduction between skin cells ... Scanning electrochemical microscopy (SECM) combined with a Transwell co-culture device has been proposed to in-situ investigate the signal transduction between ...

3. opg.optica.org opg.optica.org/abstract.cfm?uri=boe-9-4-1906

Smartphone confocal microscopy for imaging cellular ... Through many studies, RCM has been shown to provide high diagnostic accuracy for key skin diseases, including melanoma and basal cell carcinoma ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10619470/

Rapid Cellular-Resolution Skin Imaging with Optical ... We experimentally demonstrated metasurface-based multifocal OCT for rapid high-resolution skin imaging, which offers cellular resolution in the volumetric image ...

5. researchgate.net researchgate.net/figure/SECM-images-of-human-skin-obtained-from-the-ventral-forearm-in-vivo-and-in-real-time_fig5_26269048

SECM images of human skin, obtained from the ventral ... SECM images of human skin, obtained from the ventral forearm in vivo and in real time. This “en face” image of the skin was obtained at 8 frames per second ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36924183/

High-speed reflectance confocal microscopy of human skin ... These preliminary results demonstrate that high-speed SECM imaging of the human skin at 1251-1342 nm is feasible.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04566302

NCT04566302 | Pilot Study of Imaging Human Skin With ... 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 ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/lsm.23652

High‐speed reflectance confocal microscopy of human ... In this paper, we report high-speed RCM imaging of human skin with a frame rate that is over 10 times faster and an area imaging rate that is 6–9 times faster.

9. pubs.acs.org pubs.acs.org/doi/10.1021/acsmeasuresciau.2c00032

AI-Assisted Fusion of Scanning Electrochemical Microscopy ... After fusing SECM images and constructing a training data set, we used the CNN model to process image classification. CNN is a widely used model ...