Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04743362

Conditions

Skin Lesion

Mucosal Lesion

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Dermoscopic imaging

3-dimensional total body photography

Confocal microscopy

Optical Coherence Tomography imaging

Ultrasound

Study Details

Brief 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. 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

Study ID

NCT04743362

Start date

Feb 2, 2021

Status verified date

Apr, 2026

Completion date

Aug 2, 2031

Anticipated

Primary completion date

Aug 2, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Allergy or intolerance to ultrasound gel or mineral oil used for imaging
  • Patients who are not able to comply with imaging procedure

Study Design

Enrollment

5010 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Dermoscopic imaging

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 photography

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 microscopy

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 imaging

OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.

Ultrasound

US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.

Hyperspectral imaging

Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.

Electrical impedance spectroscopy

Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.

Patient self-imaging

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.

Primary outcome measure

  • Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

Manu Jain, MD

929-536-3604jainm@mskcc.org

Veronica Rotemberg, MD

646-608-2341rotembev@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Manu Jain, MD

929-536-3604

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • muco-cutaneous lesion
  • skin lesion
  • mucosal lesion
  • Memorial Sloan Kettering Cancer Center
  • 21-019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-23.