Skin LesionNCT04743362
A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions
An observational study of Skin Lesion and Mucosal Lesion, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Lesion, Mucosal Lesion
- What is being tested?
- Dermoscopic imaging, 3-dimensional total body photography and Confocal microscopy
- How many people
- 5,010 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 2 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For this study, we anticipate to recruit ~5000 participants over a period of 7 years. Of this, ~4000 will be patients with a muco-cutaneous lesion and ~1000 will be volunteers. Patients in the Dermatology, Clinical Immunology Services, Pediatrics, Bone Marrow Transplant, Dental, and Radiation Oncology departments who have a muco-cutaneous lesion/process amenable to imaging with one or more of the available noninvasive devices will be offered the opportunity to participate in the study. In addition to patients and volunteers, MSK clinicians will be recruited to the study via clinician verbal informed consent.
Who may be able to join
- All ages
- Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools
- Healthy volunteer subjects
- Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian
Who cannot join
- Allergy or intolerance to ultrasound gel or mineral oil used for imaging
- Patients who are not able to comply with imaging procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Manu Jain, MD, 929-536-3604
About this study
Official title: Noninvasive Assessment of Muco-cutaneous Lesions In Vivo
The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.
- Conditions
- Skin Lesion, Mucosal Lesion
- Being tested
- Dermoscopic imaging, 3-dimensional total body photography, Confocal microscopy, Optical Coherence Tomography imaging, Ultrasound
- Keywords
- muco-cutaneous lesion, skin lesion, mucosal lesion, Memorial Sloan Kettering Cancer Center, 21-019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermoscopic imagingDiagnostic test
The skin lesion will be imaged before application of alcohol (spray/wipe) and after application of alcohol (spray/wipe). The dermatoscope/camera with dermoscopy imaging capabilities, including but not limited to VEOS® SLR (Canfield Scientific, Inc.), will be placed on/near the area(s) of interest. Images will be captured in polarized and/or nonpolarized modes and contact and/or non-contact modes.
3-dimensional total body photographyDiagnostic test
Also called 3D TBP
Participants will stand in the center of an imaging station consisting of 92 high-resolution cameras. Image capture by all cameras will occur simultaneously, (approx. 3 milliseconds). Within a few minutes, specialized software will process and assemble the images into a 3D avatar - a digital model of the patient's skin - showing all his or her lesions.
Confocal microscopyDiagnostic test
Also called CM
CM imaging (Vivascope®, Caliber Imaging and Diagnostics, Rochester, NY) will be performed using an arm-mounted CM device (Vivascope1500, Caliber I.D., Inc.) or using a handheld CM device (Vivascope3000, Caliber I.D., Inc.).
Optical Coherence Tomography imagingDiagnostic test
Also called OCT imaging
OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.
UltrasoundDiagnostic test
Also called US
US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.
Hyperspectral imagingDiagnostic test
Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.
Electrical impedance spectroscopyDiagnostic test
Also called EIS
Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.
Patient self-imagingDiagnostic test
Clinical and dermoscopy self-imaging by patients can be accomplished using mobile phone technology. In the case of dermoscopy, this requires a small dermatoscope attachment for the phone.
| Study group | Role | What they receive |
|---|---|---|
| Participants with muco-cutaneous lesions | Participants will have muco-cutaneous lesions for non-invasive evaluation (including normal skin or mucosa and benign lesions) and will be identified by their physicians or fellows during routine clinical care. Receives: Diagnostic Test: Dermoscopic imaging; Diagnostic Test: 3-dimensional total body photography; Diagnostic Test: Confocal microscopy; Diagnostic Test: Optical Coherence Tomography imaging; Diagnostic Test: Ultrasound; Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Electrical impedance spectroscopy; Diagnostic Test: Patient self-imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions
The primary outcome of this study is to collect images from varied images devices with the dermatology service and to create an effective mechanism for the storage and dissemination of the resultant images for research purposes.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start2 Feb 2021
- Primary completion2 Aug 2031 (estimated)
- Study completion2 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manu Jain, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743362
- Sponsor's protocol ID
- 21-019
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Muco-cutaneous Lesions In Vivo
- ClinicalTrials.gov ID
- NCT04743362
- Acronym / sponsor ID
- 21-019
- Conditions
- Skin Lesion, Mucosal Lesion
- Keywords
- muco-cutaneous lesion, skin lesion, mucosal lesion, Memorial Sloan Kettering Cancer Center, 21-019
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,010 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 Aug 2031 (estimated)
- Study completion
- 2 Aug 2031 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with muco-cutaneous lesions | – | Diagnostic Test: Dermoscopic imaging, Diagnostic Test: 3-dimensional total body photography, Diagnostic Test: Confocal microscopy, Diagnostic Test: Optical Coherence Tomography imaging, Diagnostic Test: Ultrasound, Diagnostic Test: Hyperspectral imaging, Diagnostic Test: Electrical impedance spectroscopy, Diagnostic Test: Patient self-imagingParticipants will have muco-cutaneous lesions for non-invasive evaluation (including normal skin or mucosa and benign lesions) and will be identified by their physicians or fellows during routine clinical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For this study, we anticipate to recruit ~5000 participants over a period of 7 years. Of this, ~4000 will be patients with a muco-cutaneous lesion and ~1000 will be volunteers. Patients in the Dermatology, Clinical Immunology Services, Pediatrics, Bone Marrow Transplant, Dental, and Radiation Oncology departments who have a muco-cutaneous lesion/process amenable to imaging with one or more of the available noninvasive devices will be offered the opportunity to participate in the study. In addition to patients and volunteers, MSK clinicians will be recruited to the study via clinician verbal informed consent.
Key inclusion criteria (4 listed)
- All ages
- Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools
- Healthy volunteer subjects
- Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian
Key exclusion criteria (2 listed)
- Allergy or intolerance to ultrasound gel or mineral oil used for imaging
- Patients who are not able to comply with imaging procedure
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 |
|---|---|---|
| Dermoscopic imagingThe skin lesion will be imaged before application of alcohol (spray/wipe) and after application of alcohol (spray/wipe). The dermatoscope/camera with dermoscopy imaging capabilities, including but not limited to VEOS® SLR (Canfield Scientific, Inc.), will be placed on/near the area(s) of interest. Images will be captured in polarized and/or nonpolarized modes and contact and/or non-contact modes. | Diagnostic test | Participants with muco-cutaneous lesions |
| 3-dimensional total body photographyAlso: 3D TBPParticipants will stand in the center of an imaging station consisting of 92 high-resolution cameras. Image capture by all cameras will occur simultaneously, (approx. 3 milliseconds). Within a few minutes, specialized software will process and assemble the images into a 3D avatar - a digital model of the patient's skin - showing all his or her lesions. | Diagnostic test | Participants with muco-cutaneous lesions |
| Confocal microscopyAlso: CMCM imaging (Vivascope®, Caliber Imaging and Diagnostics, Rochester, NY) will be performed using an arm-mounted CM device (Vivascope1500, Caliber I.D., Inc.) or using a handheld CM device (Vivascope3000, Caliber I.D., Inc.). | Diagnostic test | Participants with muco-cutaneous lesions |
| Optical Coherence Tomography imagingAlso: OCT imagingOCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis. | Diagnostic test | Participants with muco-cutaneous lesions |
| UltrasoundAlso: USUS imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions. | Diagnostic test | Participants with muco-cutaneous lesions |
| Hyperspectral imagingHyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope. | Diagnostic test | Participants with muco-cutaneous lesions |
| Electrical impedance spectroscopyAlso: EISElectrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions. | Diagnostic test | Participants with muco-cutaneous lesions |
| Patient self-imagingClinical and dermoscopy self-imaging by patients can be accomplished using mobile phone technology. In the case of dermoscopy, this requires a small dermatoscope attachment for the phone. | Diagnostic test | Participants with muco-cutaneous lesions |
Primary outcome
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions
Time frame: 7 years
The primary outcome of this study is to collect images from varied images devices with the dermatology service and to create an effective mechanism for the storage and dissemination of the resultant images for research purposes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Manu Jain, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesion and Mucosal Lesion, run by Memorial Sloan Kettering Cancer Center 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 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manu Jain, MD (929-536-3604, jainm@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions (time frame: 7 years). 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 23 Apr 2026.