Cutaneous MelanomaNCT03699995
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
A study testing Confocal Microscopy, Dermoscopy and Imaging Procedure in people with Cutaneous Melanoma and Melanocytic Nevus, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma
- What is being tested?
- Confocal Microscopy, Dermoscopy and Imaging Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Allergy to the anesthetic (lidocaine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology.
SECONDARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma
- Being tested
- Confocal Microscopy, Dermoscopy, Imaging Procedure, Lidocaine, Punch Biopsy
- Medical subject headings
- Melanoma, Nevus, Pigmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal MicroscopyOther
Also called Confocal Laser Scanning Microscopy
Undergo confocal microscopy
DermoscopyOther
Undergo digital dermoscopy
Imaging ProcedureProcedure or surgery
Also called Diagnostic Imaging Technique, Imaging, Imaging Procedures, Imaging Technique
Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone
LidocaineDrug
Also called .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2',6'-acetoxylidide, Cuivasil, Duncaine
Given SC
Punch BiopsyProcedure or surgery
Also called Punch Biopsy of Skin
Undergo punch biopsy
Shave BiopsyProcedure or surgery
Undergo shave biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Confocal Microscopy; Other: Dermoscopy; Procedure: Imaging Procedure; Drug: Lidocaine; Procedure: Punch Biopsy; Procedure: Shave Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start18 May 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: The study did not meet its accrual goals due to the departure of study personnel. Study team opted for a study closure due to loss of key personnel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Sancy A Leachman, MD, PhD, OHSU Knight Cancer Institute
- Investigators
- Joanna Ludzik, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699995
- Sponsor's protocol ID
- STUDY00018408
- Other IDs
- NCI-2018-01152, STUDY00018408
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Modalities for Melanoma Screening and Diagnosis
- ClinicalTrials.gov ID
- NCT03699995
- Acronym / sponsor ID
- STUDY00018408
- Conditions
- Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study did not meet its accrual goals due to the departure of study personnel. Study team opted for a study closure due to loss of key personnel.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 18 May 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology.
SECONDARY OBJECTIVE:
- 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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (imaging, biopsy) | Experimental | Other: Confocal Microscopy, Other: Dermoscopy, Procedure: Imaging Procedure, Drug: Lidocaine, Procedure: Punch Biopsy, Procedure: Shave BiopsyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Allergy to the anesthetic (lidocaine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confocal MicroscopyAlso: Confocal Laser Scanning MicroscopyUndergo confocal microscopy | Other | Screening (imaging, biopsy) |
| DermoscopyUndergo digital dermoscopy | Other | Screening (imaging, biopsy) |
| Imaging ProcedureAlso: Diagnostic Imaging Technique, Imaging, Imaging Procedures, Imaging TechniqueUndergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone | Procedure or surgery | Screening (imaging, biopsy) |
| LidocaineAlso: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2',6'-acetoxylidide, Cuivasil, DuncaineGiven SC | Drug | Screening (imaging, biopsy) |
| Punch BiopsyAlso: Punch Biopsy of SkinUndergo punch biopsy | Procedure or surgery | Screening (imaging, biopsy) |
| Shave BiopsyUndergo shave biopsy | Procedure or surgery | Screening (imaging, biopsy) |
Primary outcome
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 and specificity will be estimated along with exact 95% confidence intervals.
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. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.
2 secondary outcomes
Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report
Time frame: Up to 1 year
Specificity by changes after consideration of RCM report
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: The study did not meet its accrual goals due to the departure of study personnel. Study team opted for a study closure due to loss of key personnel.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Ludzik, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal Microscopy, Dermoscopy and Imaging Procedure in people with Cutaneous Melanoma and Melanocytic Nevus, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study did not meet its accrual goals due to the departure of study personnel. Study team opted for a study closure due to loss of key personnel.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the imaging modalities (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.