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

Imaging Modalities for Melanoma Screening and Diagnosis

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.

Study Overview

• Status: Terminated
• Conditions: Skin Carcinoma; Cutaneous Melanoma; Melanocytic Nevus
• Intervention / Treatment: Procedure: Punch Biopsy; Other: Confocal Microscopy; Other: Dermoscopy; Drug: Lidocaine; Procedure: Shave Biopsy; Procedure: Imaging Procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Sancy Leachman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening (imaging, biopsy); 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.

Procedure: Punch Biopsy; Undergo punch biopsy; Other Names: Punch Biopsy of Skin; Other: Confocal Microscopy; Undergo confocal microscopy; Other Names: Confocal Laser Scanning Microscopy; Other: Dermoscopy; Undergo digital dermoscopy; Drug: Lidocaine; Given SC; Other Names: Lignocaine; .omega.-Diethylamino-2,6-dimethylacetanilide; 2-(Diethylamino)-2',6'-acetoxylidide; Cuivasil; Duncaine; Leostesin; Lidothesin; Rucaina; Procedure: Shave Biopsy; Undergo shave biopsy; Procedure: Imaging Procedure; Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone; Other Names: Diagnostic Imaging Technique; Imaging; Imaging Procedures; Medical Imaging; imaging type; imaging_type; Imaging Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the imaging modalities	Sensitivity is defined as recommend immediate biopsy (red) lesions correctly identified as red by the dermatologists. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.	Up to 1 year
Specificity of imaging modalities	Specificity is defined as green (follow-up at annual skin exam) or yellow lesions (recommend examination by dermatologist in 3 months) correctly identified. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report	Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the VisioMed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined.	Up to 1 year
Specificity by changes after consideration of RCM report	Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the Visiomed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined.	Up to 1 year

Other Outcome Measures

Outcome Measure	Time Frame
Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home	Up to 1 year

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Joanna Ludzik, MD, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Nevus; Skin and Connective Tissue Diseases; Melanoma; Nevus, Pigmented; Organic Chemicals; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Physical Phenomena; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Diagnostic Imaging; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Microscopy; Intravital Microscopy; Lidocaine; X-Rays; Microscopy, Confocal; Dermoscopy
• Other Study ID Numbers: STUDY00018408 (Other Identifier: OHSU Knight Cancer Institute); NCI-2018-01152 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes