An interventional study of Confocal Microscopy and Dermoscopy in Cutaneous Melanoma, Melanocytic Nevus and Skin Carcinoma, sponsored by OHSU Knight Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Screening
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.
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.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's enrollment of 17 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →OHSU Knight Cancer Institute is the lead sponsor of 243 studies on the registry; 44 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Undergo confocal microscopy
Also known as: Confocal Laser Scanning Microscopy
Undergo digital dermoscopy
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
Given SC
Also known as: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2',6'-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina
Undergo punch biopsy
Also known as: Punch Biopsy of Skin
Undergo shave biopsy
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.
Time frame: 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.
Time frame: Up to 1 year
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.
Time frame: 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.
Time frame: Up to 1 year
Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home
Time frame: Up to 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Dec 2025, 91 months.
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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
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