A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04743362
Status
Recruiting
Apply to this trial

Conditions

  • Mucosal Lesion
  • Skin Lesion

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.).
  • 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.
  • Ultrasound — DIAGNOSTIC_TEST
    US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 2, 2021
Status verified
Apr 2026
Primary completion
Aug 2, 2031
Completion
Aug 2, 2031

Study Design

Enrollment
5,010 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Manu Jain, MD
929-536-3604

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

Related Studies