A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Recruiting

• Conditions: Skin Lesion; Mucosal Lesion
• Interventions: Diagnostic Test: Dermoscopic imaging; Diagnostic Test: 3-dimensional total body photography; Diagnostic Test: Confocal microscopy; Diagnostic Test: Optical Coherence Tomography imaging; Diagnostic Test: Ultrasound; Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Electrical impedance spectroscopy; Diagnostic Test: Patient self-imaging

• Registration Number: NCT04743362
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2031-08-02
• Study Completion: 2031-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5010

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with muco-cutaneous lesions	3-dimensional total body photography	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.
Participants with muco-cutaneous lesions	Confocal microscopy	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.
Participants with muco-cutaneous lesions	Patient self-imaging	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.
Participants with muco-cutaneous lesions	Dermoscopic imaging	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.
Participants with muco-cutaneous lesions	Electrical impedance spectroscopy	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.
Participants with muco-cutaneous lesions	Optical Coherence Tomography imaging	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.
Participants with muco-cutaneous lesions	Ultrasound	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.
Participants with muco-cutaneous lesions	Hyperspectral imaging	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.

Primary Outcome Measures

Name	Time	Method
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States