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NCT Number: NCT04743362

A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

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.

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Key information

Conditions

Skin Lesion Mucosal Lesion

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Location status: Recruiting

Location contact

Manu Jain, MD

CONTACT

929-536-3604

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermoscopic imaging

Diagnostic 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 photography

Diagnostic Test

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.

Other names: 3D TBP

Confocal microscopy

Diagnostic Test

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.).

Other names: CM

Optical Coherence Tomography imaging

Diagnostic Test

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

Other names: OCT imaging

Ultrasound

Diagnostic Test

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

Other names: US

Hyperspectral imaging

Diagnostic Test

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

Electrical impedance spectroscopy

Diagnostic Test

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

Other names: EIS

Patient self-imaging

Diagnostic 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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manu Jain, MD

CONTACT

[email protected]

929-536-3604

Veronica Rotemberg, MD

CONTACT

[email protected]

646-608-2341

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Feb 8, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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