A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Официальное название

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

Обзор

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.

Вмешательства

• Диагностический тест 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.
• Диагностический тест 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.
• Диагностический тест 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.).
• Диагностический тест Optical Coherence Tomography imaging
  OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.
• Диагностический тест Ultrasound
  US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.
• Диагностический тест Hyperspectral imaging
  Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.
• Диагностический тест Electrical impedance spectroscopy
  Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.
• Диагностический тест 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.

Первичные конечные точки

• Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions [Срок оценки: 7 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Allergy or intolerance to ultrasound gel or mineral oil used for imaging
• Patients who are not able to comply with imaging procedure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Идентификаторы

NCT: NCT04743362 · 21-019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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