RecruitingObservational

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

NCT ID: NCT04743362Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-23

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.

Arms & 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.).
Diagnostic TestOptical Coherence Tomography imaging
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.
Diagnostic TestElectrical impedance spectroscopy
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.

Outcome measures

Primary

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.
Time frame: 7 years

Eligibility criteria

Sex: AllAge: All agesHealthy 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

Study locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting

Manu Jain, MD · Contact

929-536-3604