NCT03699995

MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma

Imaging Modalities for Melanoma Screening and Diagnosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.

Detailed description

PRIMARY OBJECTIVE: I. To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology. SECONDARY OBJECTIVE: I. To incorporate in vivo confocal images into the triage system in order to determine to what degree the information gathered in this modality changes the classification of a lesion assigned by a licensed dermatologist. TERTIARY OBJECTIVE: I. To assess the potential improvement of virtual patient triage when adding digital dermoscopy images to clinical images presented by patients to their provider (via e-visit or e-consult). OUTLINE: Participants undergo imaging of suspicious moles via smartphone application (app) MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine subcutaneously (SC) and undergo shave or punch biopsy of suspected melanomas. After completion of study intervention, patients are followed up within 1 week.

Conditions

• Cutaneous Melanoma
• Melanocytic Nevus
• Skin Carcinoma

Interventions

Type	Name	Description
OTHER	Confocal Microscopy	Undergo confocal microscopy
OTHER	Dermoscopy	Undergo digital dermoscopy
PROCEDURE	Imaging Procedure	Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone
DRUG	Lidocaine	Given SC
PROCEDURE	Punch Biopsy	Undergo punch biopsy
PROCEDURE	Shave Biopsy	Undergo shave biopsy

Timeline

• Start date: 2018-05-18
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-10-09
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study