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

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Melanocytic Nevus; Skin Carcinoma; Cutaneous Melanoma

Treatments: Procedure: Punch Biopsy; Drug: Lidocaine; Procedure: Shave Biopsy; Procedure: Imaging Procedure; Other: Confocal Microscopy; Other: Dermoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03699995

STUDY00018408 (Other Identifier)

NCI-2018-01152 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Persons who participate in the free skin cancer screening at the PDX Skincare Festival at Oregon Health & Science University (OHSU) in 2021/2022 (date pending) and are informed by a provider that they have a pigmented lesion for which a biopsy is recommended are potentially eligible to participate in this study.
• Persons who participate in the free skin cancer screening at the War on Skin Cancer event at OHSU in 2021/2022 (date pending) or other dates and locations and are informed by a provider that they have a clinically benign or atypical nevi are eligible to participate in the imaging portion of this study. No biopsy will be offered to these participants.
• Persons age 18-80 are eligible for the study
• Persons of any sex can be enrolled.
• Persons of any race are eligible but we anticipate that most participants will be Non-Hispanic whites due to the prevalence of melanoma and other skin cancers in this group.
• Only persons who can provide signed statement of informed consent will be enrolled.
• Persons who are identified in OHSU Dermatology clinics or through OHSU e-visit and e-consult platforms as having a skin lesion in need of a biopsy for skin cancer
• Persons identified via the Melanoma Community Registry (MCR) (IRB approved: 00010561)

Exclusion criteria

• Allergy to the anesthetic (lidocaine).

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Screening (imaging, biopsy)

Experimental group

Description:

Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.

Treatment:

Other: Dermoscopy

Other: Confocal Microscopy

Procedure: Imaging Procedure

Procedure: Shave Biopsy

Drug: Lidocaine

Procedure: Punch Biopsy