Imaging Techniques for Melanoma Detection

Recruiting at 1 trial location

Overseen By Sancy Leachman, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Allergy to lidocaine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if portable imaging devices can effectively detect melanoma, a type of skin cancer, as well as a dermatologist's exam. The study tests three imaging methods: MoleMapper, Visiomed, and confocal microscopy (a laser-based imaging technique). These methods capture images of moles to identify potential melanomas before they spread. Individuals may be a good fit if informed of a mole needing a biopsy during a free skin cancer screening event. As an unphased trial, this study offers an opportunity to contribute to innovative research that may improve early detection of melanoma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these imaging techniques are safe for melanoma detection?

A previous study found confocal microscopy, an imaging technique using light to examine the skin, to be safe, with no reports of harmful effects. This method allows doctors to examine skin tissue without incisions, making it non-invasive.

MoleMapper is an app that enables users to photograph their moles with a smartphone to monitor changes over time. As part of research efforts, studies have not identified any safety concerns with its use.

Visiomed is another tool that captures clear images of the skin. Like the other tools, it is non-invasive and has shown no safety issues in studies.

Overall, current research indicates these imaging tools are well-tolerated and free from harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new imaging techniques for melanoma detection because they offer a non-invasive and potentially more accessible approach to identifying suspicious moles. Unlike traditional methods that primarily rely on visual skin examination and biopsy, technologies like confocal microscopy and the MoleMapper app allow for detailed imaging of the skin at a cellular level without immediate surgical intervention. This can lead to earlier and more accurate detection of melanoma, reducing the need for unnecessary biopsies and providing peace of mind for patients. Additionally, using smartphone technology for imaging can make monitoring skin changes more convenient and user-friendly, potentially increasing patient engagement and early detection rates.

What evidence suggests that these imaging techniques are effective for melanoma detection?

Research has shown that confocal microscopy, an imaging technique used in this trial, effectively diagnoses melanoma, a type of skin cancer. It can reduce unnecessary skin biopsies by up to 40% and is used in dermatology clinics to examine skin spots. Studies have demonstrated its high accuracy in identifying skin cancer.

MoleMapper, another imaging technique in this trial, is a smartphone app designed to track and monitor moles. It is part of a research project aimed at improving melanoma detection.

Visiomed, also tested in this trial, increases the accuracy of diagnosing melanoma by 20-30% compared to examining the skin with the naked eye. This method uses computer tools to enhance early detection of skin cancer. ^{4 5 6 7 8}

Who Is on the Research Team?

Joanna Ludzik, MD

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for people aged 18-80 who have been recommended a biopsy for a suspicious mole during free skin cancer screenings at OHSU or identified through OHSU Dermatology clinics. It's also open to those with benign or atypical nevi for imaging only. Participants must be able to consent, and most are expected to be Non-Hispanic whites due to melanoma prevalence.

Inclusion Criteria

People of any race can participate, but we expect most participants to be Non-Hispanic whites because they are more likely to have melanoma and other skin cancers.

People who have been seen at OHSU Dermatology clinics or through OHSU e-visit and e-consult platforms for a skin lesion that needs a biopsy for skin cancer.

Persons identified via the Melanoma Community Registry (MCR) (IRB approved: 00010561)

Exclusion Criteria

You are allergic to the anesthetic lidocaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants undergo imaging of suspicious moles via smartphone app, digital dermoscopy, and confocal microscopy, followed by lidocaine SC and shave or punch biopsy of suspected melanomas

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study intervention

1 week

1 visit (in-person or virtual)

Long-term Monitoring

Participants' imaging results are analyzed for sensitivity and specificity over a period of up to 1 year

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Confocal Microscopy
• MoleMapper
• Visiomed

Trial Overview The study tests the effectiveness of MoleMapper, Visiomed, and confocal microscopy in detecting melanoma compared to traditional dermatologist examinations. These portable imaging techniques may help identify melanomas early without an office visit.

How Is the Trial Designed?

Group I: Screening (imaging, biopsy) Experimental Treatment 6 Interventions

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.

Confocal Microscopy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Confocal Microscopy for:

• Dermatological examinations
• Melanoma screening

Approved in United States as Confocal Microscopy for:

• Dermatological examinations
• Melanoma screening

Approved in Canada as Confocal Microscopy for:

• Dermatological examinations
• Melanoma screening

Approved in Japan as Confocal Microscopy for:

• Dermatological examinations
• Melanoma screening

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

Confocal laser-scanning microscopy (CLSM) allows for non-invasive visualization and measurement of skin capillaries in healthy individuals, demonstrating consistent parameters across different ages and sexes.

This technique offers significant advantages over traditional methods like nailfold capillaroscopy and histological analysis, enabling precise in vivo analysis of skin vasculature, which could be beneficial for diagnosing systemic and proliferative skin diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confocal laser-scanning capillaroscopy: a novel approach to the analysis of skin capillaries in vivo. Hegyi, J., Hegyi, V., Messer, G., et al.[2009]

Confocal laser scanning microscopy (CLSM) is a highly effective imaging technique for evaluating superficial skin tumors, allowing for noninvasive, real-time assessment of tumor characteristics and associated vasculature.

CLSM can help differentiate between various histologic subtypes of skin tumors, guiding treatment decisions and improving monitoring of disease progression without causing damage to the skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future applications of confocal laser scanning microscopy imaging in skin oncology. Ilie, MA., Caruntu, C., Lupu, M., et al.[2023]

Recent advancements in confocal microscopy have improved the in vivo diagnosis of melanoma and the pre-operative mapping of melanoma margins, enhancing surgical precision.

New technologies, such as mosaicing microscopy and low-cost line-scanning confocal microscopes, aim to facilitate rapid diagnosis and treatment of skin cancers in various healthcare settings, making these tools accessible worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confocal microscopy of skin cancers: translational advances toward clinical utility. Rajadhyaksha, M.[2021]

In a study analyzing 857 confocal laser scanning microscopy (CLSM) images of skin tumors, the classification tree analysis (CART) accurately identified 97.55% of melanoma images and 96.32% of benign nevi, demonstrating high efficacy in distinguishing between these skin conditions.

The study revealed that certain morphological features, such as monomorphic melanocytic cells in benign nevi and polymorphic cells in melanoma, can be objectively analyzed, suggesting that CLSM can enhance diagnostic accuracy beyond traditional visual assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of image analysis features and visual morphology in melanocytic skin tumours using in vivo confocal laser scanning microscopy. Lorber, A., Wiltgen, M., Hofmann-Wellenhof, R., et al.[2009]

Non-invasive skin imaging techniques, such as confocal microscopy, are being increasingly used in dermatology to aid in the early diagnosis of skin cancers, potentially reducing the need for unnecessary biopsies.

Advancements in confocal microscopy, including the use of fluorescent dyes and artificial intelligence, are enhancing the accuracy and effectiveness of skin cancer diagnosis and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confocal Microscopy for Diagnosis and Management of Cutaneous Malignancies: Clinical Impacts and Innovation. Atak, MF., Farabi, B., Navarrete-Dechent, C., et al.[2023]

Early detection and removal of melanoma significantly improves patient prognosis and survival rates, highlighting the importance of effective detection methods.

The chapter reviews various advanced detection technologies, including in vivo confocal microscopy and noninvasive optical biopsies, which may enhance the accuracy of melanoma diagnosis compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods of Melanoma Detection. Leachman, SA., Cassidy, PB., Chen, SC., et al.[2015]

Confocal laser scanning microscopy (CLSM) provides clearer images of living cells in the skin by eliminating out-of-focus blur, making it superior to conventional microscopy for detailed analysis.

CLSM has significant potential for future applications in dermatology, allowing for detailed imaging of both fixed and living tissues, which could enhance diagnostic capabilities and research in skin-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confocal laser scanning microscopy: a new optical microscopic technique for applications in pathology and dermatology. Fink-Puches, R., Hofmann-Wellenhof, R., Smolle, J., et al.[2019]

Artificial intelligence-driven ex vivo confocal microscopy (XVM) can effectively mimic standard histopathology images and produce automated tumor positivity maps, showing a diagnostic sensitivity of 88% and specificity of 91% for detecting basal cell carcinoma.

The XVM method is potentially faster and less costly than traditional histopathology, making it a promising tool for determining margin status in Mohs micrographic surgery for skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep learning automated pathology in ex vivo microscopy. Combalia, M., Garcia, S., Malvehy, J., et al.[2022]

Ex vivo confocal microscopy has improved the speed and accuracy of skin cancer pathology assessments by allowing detailed visualization of cellular structures in both paraffin-embedded and frozen samples.

Recent advancements include new staining protocols and multimodal imaging techniques that enhance diagnostic capabilities without compromising traditional histopathology methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex vivo confocal microscopy: revolution in fast pathology in dermatology. Malvehy, J., Pérez-Anker, J., Toll, A., et al.[2021]

Confocal scanning laser microscopy (CSLM) demonstrated a higher sensitivity (97.3%) compared to dermoscopy (89.2%) in diagnosing melanocytic lesions, indicating it may be more effective in detecting melanomas early.

Both CSLM and dermoscopy showed similar specificity (around 83%), suggesting that they can be used together as complementary tools to improve diagnostic accuracy for melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnostic accuracy of in vivo confocal scanning laser microscopy compared to dermoscopy of benign and malignant melanocytic lesions: a prospective study. Langley, RG., Walsh, N., Sutherland, AE., et al.[2007]

Confocal laser scanning microscopy (CLSM) is a promising noninvasive technique for analyzing skin structure in real-time, which can enhance both dermatological research and clinical management of skin cancer patients.

CLSM has various clinical applications in dermatology, making it a valuable tool for improving diagnosis and treatment strategies in skin-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo confocal microscopy in dermatology: from research to clinical application. Ulrich, M., Lange-Asschenfeldt, S.[2019]

In vivo confocal laser scanning microscopy (CLSM) demonstrated high diagnostic accuracy for skin tumors, achieving a sensitivity of 97.5% and specificity of 99% when evaluating 3709 images from 20 malignant melanomas and 50 benign naevi.

A three-step diagnostic algorithm based on three key morphological features from CLSM images allowed for correct classification of 92.4% of benign naevi and 97.6% of melanoma cases, suggesting CLSM could be a valuable tool for skin cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo confocal laser scanning microscopy of melanocytic skin tumours: diagnostic applicability using unselected tumour images. Gerger, A., Hofmann-Wellenhof, R., Langsenlehner, U., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6444326/

Current and future applications of confocal laser scanning ... Confocal laser scanning microscopy (CLSM) is a modern imaging technique that enables the in vivo or ex vivo characterization of skin lesions.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224029566

Remote cutaneous confocal microscopy: A multicentric ... Remote interpretation of reflectance confocal microscopy can potentially reduce the number of unnecessary biopsies for skin malignancies by up to 40%, with a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3839827/

Systematic review of diagnostic accuracy of reflectance ... Reflectance confocal microscopy may contribute to the diagnosis of melanoma as an add-on test in the diagnostic pathway to reduce over-diagnosis following ...

4. mdpi.com mdpi.com/2075-4418/13/5/854

Confocal Microscopy for Diagnosis and Management of ... In this review article, we will discuss in vivo and ex vivo confocal microscopy (CM) techniques that are currently being utilized in dermatology clinics for ...

5. bcbsri.com bcbsri.com/providers/sites/providers/files/policies/2025/02/2025%20Reflectance%20Confocal%20Microscopy%20for%20Evaluating%20Skin%20Lesions%20for%20Suspected%20Malignancy.pdf

Reflectance confocal microscopy (RCM) is a relatively new ... Studies evaluating the accuracy of confocal scanning laser. RCM/CSLM in assessing skin lesions for melanoma have reported sensitivity, specificity, positive and.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11719492/

Benign or Malignant? Ex Vivo Confocal Laser Scanning ... This study explores the use of ex vivo confocal laser scanning microscopy (EVCM), a rapid imaging technique, to examine fresh tissue immediately after surgical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6122529/

Advances in the use of reflectance confocal microscopy in ... With the use of RCM, sensitivity was 84.4% and specificity 56%. All melanomas misclassified by either dermoscopy or RCM were detected by the other tool. RCM ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.21910

Sensitivity and specificity of confocal laser‐scanning ... CLSM is a novel, high‐resolution imaging technique that opens a window into living tissue. It has been deemed a safe procedure with no evidence ...