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

NCT03699995 | Terminated FDA Device

• 2 other identifiers: STUDY00018408NCI-2018-01152
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Melanoma; Melanocytic Nevus; Skin Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report

  Up to 1 year

• Specificity by changes after consideration of RCM report

  Up to 1 year

Other Outcomes (1)

• Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home

  Up to 1 year

Study Arms (1)

Screening (imaging, biopsy)

EXPERIMENTAL

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.

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

Interventions

Confocal Microscopy OTHER

Undergo confocal microscopy

Also known as: Confocal Laser Scanning Microscopy

Screening (imaging, biopsy)

Dermoscopy OTHER

Undergo digital dermoscopy

Screening (imaging, biopsy)

Imaging Procedure PROCEDURE

Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone

Also known as: Diagnostic Imaging Technique, Imaging, Imaging Procedures, Imaging Technique, imaging type, imaging_type, Medical Imaging

Screening (imaging, biopsy)

Lidocaine DRUG

Given SC

Also known as: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2',6'-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina

Screening (imaging, biopsy)

Punch Biopsy PROCEDURE

Undergo punch biopsy

Also known as: Punch Biopsy of Skin

Screening (imaging, biopsy)

Shave Biopsy PROCEDURE

Undergo shave biopsy

Screening (imaging, biopsy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Allergy to the anesthetic (lidocaine).

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Sancy Leachman

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Melanoma; Nevus, Pigmented

Interventions

Microscopy, Confocal; Dermoscopy; X-Rays; Lidocaine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Nevus

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Intravital Microscopy; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Joanna Ludzik, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: May 18, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)