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Clinical Trials/NCT04743362
NCT04743362
Recruiting
Not Applicable

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

Memorial Sloan Kettering Cancer Center1 site in 1 country5,010 target enrollmentFebruary 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin Lesion
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
5010
Locations
1
Primary Endpoint
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2021
End Date
August 2, 2031
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions

Time Frame: 7 years

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.

Study Sites (1)

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