Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Phase: NA
Conditions: Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles, Skin Lesion
Sponsor: Massachusetts General Hospital

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY PROTOCOL   
 
Pilot Study for Imaging Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
VERSION/DATE 
Version 1.7 
08/16/2022 
 
MGH PRINCIPAL INVESTIGATOR  
 
Guillermo Tearney, MD, PhD 
Address: MGH; BHX 605 
Telephone: 617-724-2979 
Email: gtearney@partners.org 
 
 
 
 
 
 
 
 
 
 
 

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
2. SPECIFIC AIMS: 
To evaluate the imaging performance of Spectrally Encoded Confocal Microscopy for imaging 
human skin.  
3. SUBJECT SELECTION: 
 
A total of 20 subjects, healthy adults 18 years and older, working at the Wellman Center for 
Photomedicine will be enrolled in this study. 
 
INCLUSION CRITERIA: 
• Healthy adults  
• 18 years of age or older  
• Capable of giving informed consent 
• Pigmented skin lesions (such as moles, beauty marks, or sunspots) present on the upper 
arm, elbow, forearm or hand  
 
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 
 
RECRUITMENT METHODS: 
An advertisement will be posted on the internal website of the Wellman Center for Photomedicine 
and an email will be sent to all the employees of the Wellman Centre for photomedicine informing 
them of this study. An information packet, containing a copy of a recruitment letter and the 
research center contact information will be sent to individuals who express interest. No subjects 
under the direct supervision of the investigators will be recruited to this study. The research 
nurse/coordinator will follow up with a phone call to assess interest in participating in the study, 
review eligibility, explain the study further and answer any questions. The contact details of the 
study staff will be provided to all potential subjects to be able to contact the research team with 
any questions or concerns regarding the research study prior to the exam.  
 
If a potential subject is interested in participating in this study, he/she will be scheduled to be 
imaged. To be certain that all subjects understand the study procedure and have an opportunity to 
change their mind about participation, the potential subjects will be able to discuss the study again 
with the clinical staff such as a study nurse, clinical research fellow or physician. Informed consent 
will be obtained prior to the procedure by a clinical research nurse or a clinical research fellow. 
  
4. STUDY PROCEDURES:  
 

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
• DEVICE DESCRIPTION:  
 
 
 
• PROCEDURE 
Study procedures will take place in the Bartlett building at the Wellman Center for Photomedicine. 
The subject will be asked to sit on a chair and relax the area being imaged (upper arm, elbow, 
forearm, or hand). There will be no sedation or medication involved. 
The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. 
First, the pigmented skin lesion (such as a mole) will be identified on either the upper arm, elbow, 
forearm, or hand of the subject by a clinician or trained study staff. The lesion will be imaged first 
with a dermatoscope, and then with the SECM probe. 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 (7).  
 
  
 
After the lesion is scanned with the dermatoscope, we will image the lesion with the SECM skin 
imaging probe. We may use either the fluorinated ethylene propylene (FEP) imaging window 
cover, or separate components (double sided tape, cover glass, and metal ring) as attachments to 
the probe to assist with probe imaging. The FEP sheet and film used for the imaging window are 
FDA compliant. 
 
 
 
 If the 
FEP imaging window cover is used during the procedure, then no other components (double sided 
tape, cover glass, and metal ring)  are necessary.  
If the FEP window is not used for imaging, other components will be used during imaging with 
SECM imaging probe. A small amount of double-sided tape in the shape of a ring will be placed 
around the identified skin lesion. Water or ultrasound gel will be placed on the skin lesion and a 
No 2 cover glass will be placed on the double-sided tape. A thin metal ring will be placed on the 
double-sided tape. Ultrasound gel will be placed on the cover glass (Figure 1). 
 
 A clinician or trained study staff will 
connect the skin SECM imaging probe (Figure 3) to the electronic box and the SECM console. 
Once the connections are secured both the console and electronics box will be turned on. The 
SECM laser will be turned on and SECM skin imaging will be conducted on the skin lesion. We 
will image both the skin lesion and the section of nearby normal skin area.  

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
For any given skin lesion, we will collect up to 3 confocal image stacks (
 
) from both non-pigmented and pigmented areas, for each subject. 
Once the SECM imaging is completed, the SECM skin imaging setup will be removed from the 
area being imaged (upper arm, elbow, forearm or hand) of the subject, as well as the metal ring 
and the double-sided tape. Subjects will be asked to wash the area of skin that is in contact with 
the FEP window or separate components, following the procedure. 
 
Figure 1: 
.  
 
Figure 2: 
 

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
 
 
  
5. COSTS 
The experimental procedure will be done at no cost to the subject or his/her insurance company 
and the subjects will not be responsible for any costs incurred for participation in this study. 
The subjects will receive a $50 gift card for their time.  
6. BIOSTATISTICAL ANALYSIS:    
This will be a prospective, nonrandomized pilot study. This study is designed as a feasibility study, 
which may serve as the basis for future larger-scale studies. 
 
7. RISKS AND DISCOMFORT:  
SECM imaging is low risk, non-invasive imaging technique. We have previously demonstrated the 
safety of the SECM device in the form of a capsule endoscope. SECM imaging technology has 
been used to image the esophagus’ of over 60 human subjects, without any serious adverse events 
or complications.  
The SECM laser can produce 5.5 mW of optical power at a wavelength of 1300 nm on the tissue, 
which is a class 3R device and safe for both eyes and skin. Therefore, the subject’s skin tissue has 
very low chance to be damaged under our laser illumination. For the eye safety, the laser will be 
turned on only while the device has been introduced to the subject skin and the system is acquiring 
the images. Since the objective lens with high numerical aperture of 0.95 and short working distance 
of 180 µm, it is impossible to see the beam spot for the patient or the operator during the imaging. 
Even if they could see the spot, the beam is highly diverging and its wavelength (1300 nm) is in the 
high attenuation range of the water, it is unlikely to damage the retina. 
The dermatoscope that will be used in this study is a commercially available, smart phone 
dermatoscope, designed to be attached to a cell phone or a tablet. It consists of LED lighting, a full-
size 15 mm optical lens, a polarizer, and a mounting case. It has been approved by the FDA for use 
to image human skin.  
The fluorinated ethylene propylene (FEP) sheet and film used in the imaging window are FDA 
compliant, and are considered low-risk by the FDA for biocompatibility when in contact with 
intact human skin. FEP is an excellent electrical insulator, and is resistant to high temperatures, 
UV and chemicals (10,11). FEP is not likely to be hazardous when in contact with intact skin, and 
no irritant effects are anticipated. However, to mitigate any possible discomforts, subjects will be 
asked to wash the area of skin that is in contact with the FEP imaging window and other 
components following the imaging procedure. 

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
In order to minimize a potential risk of breach of confidentiality, any imaging data, and any other 
subject information will be assigned a unique subject ID number. All other personal information 
will be removed. A master log will be maintained with full names and medical record numbers, 
which will be secured in the locked office. This will be accessible only when deemed necessary and 
only to members of the study team. 
We will collaborate with Prof. Dongkyun Kang, Assistant Professor of Biomedical Engineering at 
the University of Arizona and will be sharing coded subject data with him. 
We will also be collaborating with Dr. Jihuen Ryu who is a former post-doctoral fellow who worked 
on technological development of the devices, we will be sharing deidentified subject data with Dr. 
Jihuen Ryu.   
8. POTENTIAL BENEFITS 
There are no direct benefits for the individual subjects participating in the study. The individuals 
with skin disorders may benefit in the future from what we learn in this study. 
9. MONITORING AND QUALITY ASSURANCE 
Dr. Tearney is the Principal Investigator of this study and is directly responsible for the conduct 
of the study. Dr. Tearney will be responsible for ensuring that the study is conducted according to 
the IRB-approved protocol and regulations, and for protecting the rights, safety and welfare of the 
subjects. Dr. Tearney is also responsible for reporting any unexpected and adverse events to the 
IRB. According to the Partners Human Research Committee (PHRC) guidelines, unexpected 
adverse events will be reported to the PHRC within the required time frame as determined by the 
PHRC requirements. 
All imaging data obtained as a part of this research study will be reviewed by Dr. Guillermo 
Tearney, an expert in this type of imaging. Although rare, there is a possibility that while reviewing 
the research imaging we may see something that we did not expect to see. We call this a “finding.” 
If we think the finding could be important to the research participant’s health, we will contact them 
to find out if they would like to learn more. If it is unclear how to best communicate the information 
to the participant, the IRB will be contacted for guidance. Whenever a finding is communicated to 
a research participant, an “Other Event” (OE) will be submitted to the IRB and internal 
documentation will be filed appropriately.   
 
 
10.  REFERENCES 
1.  Rajadhyaksha M, Marghoob A, Rossi A, Halpern AC, Nehal KS. Reflectance Confocal 
Microscopy of Skin In Vivo: From Bench to Bedside. Lasers Surg Med. 2017 Jan;49(1):7–
19.  

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022 
2.  Xiong YD, Ma S, Li X, Zhong X, Duan C, Chen Q. A meta-analysis of reflectance confocal 
microscopy for the diagnosis of malignant skin tumours. J Eur Acad Dermatol Venereol 
JEADV. 2016 Aug;30(8):1295–302.  
3.  Rajadhyaksha M, Marghoob A, Rossi A, Halpern AC, Nehal KS. Reflectance Confocal 
Microscopy of Skin In Vivo: From Bench to Bedside. Lasers Surg Med. 2017 Jan;49(1):7–
19.  
4.  Boudoux C, Yun SH, Oh WY, White WM, Iftimia NV, Shishkov M, et al. Rapid 
wavelength-swept spectrally encoded confocal microscopy. Opt Express. 2005 Oct 
3;13(20):8214–21.  
5.  Schlachter SC, Kang D, Gora MJ, Vacas-Jacques P, Wu T, Carruth RW, et al. Spectrally 
encoded confocal microscopy of esophageal tissues at 100 kHz line rate. Biomed Opt 
Express. 2013 Aug 13;4(9):1636–45.  
6.  Brachtel EF, Johnson NB, Huck AE, Rice-Stitt TL, Vangel MG, Smith BL, et al. Spectrally 
Encoded Confocal Microscopy (SECM) for Diagnosing of Breast Cancer in Excision and 
Margin Specimens. Lab Investig J Tech Methods Pathol. 2016 Apr;96(4):459–67.  
7.  Dermascope - Medical Device | AMD Global Telemedicine [Internet]. [cited 2018 Jun 28]. 
Available from: https://www.amdtelemedicine.com/telemedicine-
equipment/dermascope.html 
8.   Kang, D., Carruth, R. W., Kim, M., Schlachter, S. C., Shishkov, M., Woods, K., Tabatabaei, 
N., Wu, T., & Tearney, G. J. (2013). Endoscopic probe optics for spectrally encoded 
confocal microscopy. Biomedical optics express, 4(10), 1925–1936. 
https://doi.org/10.1364/BOE.4.001925 
9.   Tabatabaei, N., Kang, D., Wu, T., Kim, M., Carruth, R. W., Leung, J., Sauk, J. S., Shreffler, 
W., Yuan, Q., Katz, A., Nishioka, N. S., & Tearney, G. J. (2013). Tethered confocal 
endomicroscopy capsule for diagnosis and monitoring of eosinophilic 
esophagitis. Biomedical optics express, 5(1), 197–207. 
https://doi.org/10.1364/BOE.5.000197 
10. M. (n.d.). Rulon PTFE, FEP & Polysulfone. Retrieved 
https://www.mcmaster.com/catalog/126/3862 
11. FDA. (2020, October 15). Select Updates for Biocompatibility of Certain Devices in Contact 
with Intact Skin. Www.Fda.Gov. https://www.fda.gov/media/142959/download 
 
 
 
 

Tearney Lab, Wellman Center for Photomedicine, Massachusetts General Hospital (MGH) 
Study Protocol Title: Pilot Study for Imaging of Human Skin with High-Speed Spectrally Encoded Confocal Microscopy 
 
 
 
Version 1.7 
08/16/2022