A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions
Noninvasive Assessment of Muco-cutaneous Lesions In Vivo
1 other identifier
observational
5,010
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2021
CompletedFirst Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 2, 2031
April 23, 2026
April 1, 2026
10.5 years
February 3, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 years
Study Arms (1)
Participants with muco-cutaneous lesions
Participants will have muco-cutaneous lesions for non-invasive evaluation (including normal skin or mucosa and benign lesions) and will be identified by their physicians or fellows during routine clinical care.
Interventions
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.
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.
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.).
US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.
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.
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.
OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Allergy or intolerance to ultrasound gel or mineral oil used for imaging
- Patients who are not able to comply with imaging procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manu Jain, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2021
First Posted
February 8, 2021
Study Start
February 2, 2021
Primary Completion (Estimated)
August 2, 2031
Study Completion (Estimated)
August 2, 2031
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.