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

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ClinicalTrials.gov Identifier: NCT03699995
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Pamela Cassidy, OHSU Knight Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Cutaneous Melanoma Healthy Subject Melanocytic Nevus Skin Carcinoma Other: Confocal Microscopy Procedure: Imaging Technique Drug: Lidocaine Procedure: Punch Biopsy Procedure: Shave Biopsy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the clinical utility of images collected by an iPhone application (app) MoleMapper, and a professional grade portable imaging system (Visiomed microDERM DL200evo imaging system or 'Visiomed'), a commonly used polarized-light dermatoscope, the DermLite DL4 joined to a research iPhone used by the MoleMapper team, as well as assessment of the use of in vivo confocal microscopy for teledermatology.

II. 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 board-certified dermatologist.

OUTLINE:

Participants undergo imaging of suspicious moles via iPhone app MoleMapper, Visiomed, and confocal microscopy. Participants then receive lidocaine subcutaneously (SC) and undergo shave or punch biopsy of suspected melanomas.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Imaging Modalities for Melanoma Screening
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : July 26, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: Screening (MoleMapper, Visiomed, confocal microscopy, biopsy)
Participants undergo imaging of suspected melanomas via iPhone app MoleMapper, Visiomed, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
Other: Confocal Microscopy
Undergo confocal microscopy
Other Name: Confocal Laser Scanning Microscopy

Procedure: Imaging Technique
Undergo MoleMapper imaging with iPhone
Other Names:
  • Diagnostic Imaging Technique
  • imaging
  • imaging procedure
  • Imaging Procedures
  • Medical Imaging

Procedure: Imaging Technique
Undergo Visiomed imaging
Other Names:
  • Diagnostic Imaging Technique
  • imaging
  • imaging procedure
  • Imaging Procedures
  • Medical Imaging

Drug: Lidocaine
Given SC
Other Names:
  • .omega.-Diethylamino-2,6-dimethylacetanilide
  • 2-(Diethylamino)-2',6'-acetoxylidide
  • Cuivasil
  • Duncaine
  • Leostesin
  • Lidothesin
  • Lignocaine
  • Rucaina

Procedure: Punch Biopsy
Undergo punch biopsy
Other Name: Punch Biopsy of Skin

Procedure: Shave Biopsy
Undergo shave biopsy




Primary Outcome Measures :
  1. Sensitivity of the imaging modalities [ Time Frame: Up to 1 year ]
    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 will be estimated along with exact 95% confidence intervals.

  2. Specificity of imaging modalities [ Time Frame: Up to 1 year ]
    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. Specificity will be estimated along with exact 95% confidence intervals.


Secondary Outcome Measures :
  1. Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report [ Time Frame: Up to 1 year ]
    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.

  2. Specificity by changes after consideration of RCM report [ Time Frame: Up to 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons who participate in the free skin cancer screening at the PDX Skincare Festival at Oregon Health & Science University (OHSU) on May 19, 2018 and May 18, 2019 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 on May 19, 2018 and May 18, 2019 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 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.

Exclusion Criteria:

  • Persons who have not participated in the free skin cancer screening are not eligible to participate in this study.
  • Allergy to the anesthetic (lidocaine).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699995


Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Pamela Cassidy    503-494-9047    cassidyp@ohsu.edu   
Principal Investigator: Pamela Cassidy         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Investigators
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Principal Investigator: Pamela Cassidy OHSU Knight Cancer Institute
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Responsible Party: Pamela Cassidy, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03699995    
Other Study ID Numbers: STUDY00018408
NCI-2018-01152 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00018408 ( Other Identifier: OHSU Knight Cancer Institute )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Nevus, Pigmented
Nevus
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action