A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dermoscopic imaging, 3-dimensional total body photography, Confocal microscopy, Optical Coherence Tomography imaging.
- Who it may be relevant to
- Registry conditions: Skin Lesion, Mucosal Lesion. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Noninvasive Assessment of Muco-cutaneous Lesions In Vivo
Overview
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 test 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. - Diagnostic test 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. - Diagnostic test 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.). - Diagnostic test Optical Coherence Tomography imaging
OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis. - Diagnostic test Ultrasound
US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions. - Diagnostic test Hyperspectral imaging
Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope. - Diagnostic test Electrical impedance spectroscopy
Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions. - Diagnostic test 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 measures
- Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions [Time frame: 7 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Identifiers
NCT: NCT04743362 · 21-019