A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

ConditionsSkin Lesion Mucosal Lesion

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Allergy or intolerance to ultrasound gel or mineral oil used for imaging

Patients who are not able to comply with imaging procedure

Trial population

For this study, we anticipate to recruit \~5000 participants over a period of 7 years. Of this, \~4000 will be patients with a muco-cutaneous lesion and \~1000 will be volunteers. Patients in the Dermatology, Clinical Immunology Services, Pediatrics, Bone Marrow Transplant, Dental, and Radiation Oncology departments who have a muco-cutaneous lesion/process amenable to imaging with one or more of the available noninvasive devices will be offered the opportunity to participate in the study. In addition to patients and volunteers, MSK clinicians will be recruited to the study via clinician verbal informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

5,010 Participants

are divided into 1 treatment group

Group A: Participants with muco-cutaneous lesions8 interventions

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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