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A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04743362
Enrollment
5010
Registered
2021-02-08
Start date
2021-02-02
Completion date
2031-08-02
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Lesion, Mucosal Lesion

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTDermoscopic 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.

DIAGNOSTIC_TEST3-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.

DIAGNOSTIC_TESTConfocal 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.).

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

DIAGNOSTIC_TESTUltrasound

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

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

DIAGNOSTIC_TESTPatient 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions7 yearsThe 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.

Countries

United States

Contacts

CONTACTManu Jain, MD
jainm@mskcc.org929-536-3604
CONTACTVeronica Rotemberg, MD
rotembev@mskcc.org646-608-2341
PRINCIPAL_INVESTIGATORManu Jain, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026