What side effects are associated with this type of intervention?

Non-invasive imaging techniques such as MoleMapper, Visiomed, and confocal microscopy generally have minimal side effects, primarily limited to temporary skin irritation or redness at the site of imaging. Photodynamic therapy (PDT), used for treating actinic keratoses and superficial basal cell carcinomas, can cause side effects like burning, blistering, and pruritus. Topical treatments, such as imiquimod and 5-fluorouracil, may lead to local skin reactions including redness, swelling, and peeling. Long-term side effects of these treatments are generally minimal but can include changes in skin pigmentation and scarring.

What prior FDA approvals exist?

The FDA has approved several treatments for skin cancer, including advanced imaging techniques and related drugs. Photographic imaging and laser scanning, such as those studied in MoleMapper, Visiomed, and confocal microscopy trials, are used for early detection of melanoma. These non-invasive methods help in identifying suspicious lesions that may require further examination or biopsy. Additionally, drugs like imiquimod and photodynamic therapy (using agents like delta-aminolevulinic acid) have been approved for treating certain types of skin cancers, including basal cell carcinoma and actinic keratosis. These treatments highlight the FDA's commitment to advancing both diagnostic and therapeutic options for skin cancer.

What other types of research exist?

Promising novel alternatives for melanoma detection in 2024 include artificial intelligence (AI)-powered dermoscopy, which uses machine learning algorithms to analyze skin lesions with high accuracy, and optical coherence tomography (OCT), which provides high-resolution cross-sectional images of the skin. Additionally, reflectance confocal microscopy (RCM) combined with AI for enhanced image analysis and multispectral imaging techniques that capture data across different wavelengths are also emerging as effective tools for early melanoma detection.

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Imaging Technique

Imaging Techniques for Melanoma Detection

N/A

Recruiting

Led By Pamela Cassidy

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Persons age 18-80 are eligible for the study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if smartphone apps and special cameras can detect melanoma as well as a dermatologist. It targets people with suspicious moles and uses advanced imaging technology to spot skin cancer early.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects mainly involve the biopsy procedures which can include discomfort from lidocaine injection and minor bleeding, bruising, or infection at the biopsy site. Allergic reactions to lidocaine are possible but participants with such allergies are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity of the imaging modalities

Specificity of imaging modalities

Secondary study objectives

Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report

Specificity by changes after consideration of RCM report

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (imaging, biopsy)Experimental Treatment6 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine

2011

Completed Phase 4

~1370

Punch Biopsy

2017

N/A

~40

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for skin cancer, particularly melanoma, include surgical excision, photodynamic therapy, and topical treatments like imiquimod. Imaging technologies such as MoleMapper, Visiomed, and confocal microscopy are used for early detection and monitoring. These imaging systems work by capturing detailed images of the skin, allowing for the identification of abnormal cells before they spread. This early detection is crucial for skin cancer patients as it significantly improves treatment outcomes and survival rates. Photodynamic therapy involves applying a photosensitizing agent to the skin, which is then activated by light to destroy cancer cells. Imiquimod works by stimulating the immune system to attack cancerous cells. These treatments are essential as they offer non-invasive or minimally invasive options, reducing the need for extensive surgery and improving the quality of life for patients.

Efficacy of narrow-band ultraviolet-B therapy in patch-stage mycosis fungoides: A clinical study and review of the literature.5% imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma.