Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-23 @ 5:49 AM
Study NCT ID:
NCT03699995
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Imaging Modalities for Melanoma Screening and Diagnosis
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: