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

Primary Purpose

Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Confocal Microscopy
Dermoscopy
Imaging Technique
Lidocaine
Punch Biopsy
Shave Biopsy
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cutaneous Melanoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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) 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 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).

Sites / Locations

  • OHSU Knight Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (imaging, biopsy)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 5, 2018
Last Updated
August 17, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03699995
Brief Title
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
Official Title
Imaging Modalities for Melanoma Screening and Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening (imaging, biopsy)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Confocal Microscopy
Other Intervention Name(s)
Confocal Laser Scanning Microscopy
Intervention Description
Undergo confocal microscopy
Intervention Type
Other
Intervention Name(s)
Dermoscopy
Intervention Description
Undergo digital dermoscopy
Intervention Type
Procedure
Intervention Name(s)
Imaging Technique
Other Intervention Name(s)
Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, imaging type, imaging_type, Medical Imaging
Intervention Description
Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
.omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2',6'-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina
Intervention Description
Given SC
Intervention Type
Procedure
Intervention Name(s)
Punch Biopsy
Other Intervention Name(s)
Punch Biopsy of Skin
Intervention Description
Undergo punch biopsy
Intervention Type
Procedure
Intervention Name(s)
Shave Biopsy
Intervention Description
Undergo shave biopsy
Primary Outcome Measure Information:
Title
Sensitivity of the imaging modalities
Description
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.
Time Frame
Up to 1 year
Title
Specificity of imaging modalities
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report
Description
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.
Time Frame
Up to 1 year
Title
Specificity by changes after consideration of RCM report
Description
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.
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Ludzik, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Ludzik, MD
Phone
503-418-3376
Email
ludzik@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Joanna Ludzik, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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