DermaSensor Device for Skin Cancer Detection

Recruiting at 1 trial location

Overseen By Justin Frazier, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DermaSensor, Inc.

Disqualifiers: Psoriasis, Eczema, Acne, Dementia, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

396 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the DermaSensor, designed to assist doctors in detecting skin cancer, specifically melanoma, by scanning suspicious skin lesions. The study evaluates the device's effectiveness when used alongside a doctor's usual assessment of whether a lesion requires a biopsy. Individuals with a skin lesion that might be melanoma and who are willing to undergo a scan with the DermaSensor may be suitable for this trial. The trial aims to improve early detection of skin cancer, potentially making diagnosis quicker and easier. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance early skin cancer detection.

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 the DermaSensor device is safe for skin cancer detection?

Research has shown that the DermaSensor device is safe for use on potentially cancerous skin spots. Tested in several studies, it assists doctors in determining if a skin spot could be cancerous. The device analyzes the spot and provides quick results.

The FDA has approved the DermaSensor for checking skin spots that might be melanoma, basal cell carcinoma, and squamous cell carcinoma. This approval confirms it meets safety standards for these uses.

Regarding side effects, the DermaSensor is non-invasive, meaning it does not break the skin or enter the body, avoiding the risks associated with more invasive tests or procedures. Overall, evidence indicates that the DermaSensor is well-tolerated and safe for evaluating suspicious skin spots. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DermaSensor Device for skin cancer detection because it offers a novel way to enhance clinical assessments. Unlike standard options that rely solely on visual examination and the clinician's judgment for biopsy decisions, this device provides additional data through its sensor output. This feature could improve accuracy by helping doctors make more informed decisions about which skin lesions to biopsy. By integrating this innovative tool into practice, there's potential to catch skin cancer earlier and reduce unnecessary procedures.

What evidence suggests that the DermaSensor device is effective for skin cancer detection?

Research has shown that the DermaSensor device effectively detects skin cancer, particularly melanoma. Studies have found it has a sensitivity of 95.5%, allowing it to identify cancerous spots more accurately than many primary care doctors, who have a sensitivity rate of 83.0%. The device has also increased melanoma detection rates from 70.2% to 79.1%, reducing missed cases. In this trial, some participants will undergo clinical assessment with the device output, while others will have clinical assessment only. The DermaSensor is a handheld tool that helps doctors decide more accurately whether a biopsy is needed. This device is designed to be an easy and reliable way to support skin cancer detection during medical visits. ^{1 6 7 8 9}

Who Is on the Research Team?

Gary Slatko, MD, MBA

Principal Investigator

DermaSensor, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with skin lesions that may be concerning for melanoma or other types of skin cancer. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

I am 40 years old or older.

Patient is willing and able to read, understand, and sign the informed consent form (ICF)

I have a skin lesion that may be melanoma.

Exclusion Criteria

Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)

Lesion is greater than 15mm in diameter at the widest point

Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Assessment

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Scan with DermaSensor Device

Trial Overview

The trial is testing a device called DermaSensor, which uses elastic scattering spectroscopy to assess the risk of malignancy in skin lesions. The goal is to evaluate how sensitive this device and the investigators are at detecting potential melanomas.

How Is the Trial Designed?

Group I: Clinical assessment with device output Experimental Treatment 1 Intervention

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output

Group II: Clinical assessment only Active Control 1 Intervention

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output

Scan with DermaSensor Device is already approved in United States, European Union for the following indications:

Approved in United States as DermaSensor Device for:

• Melanoma
• Basal Cell Carcinoma
• Squamous Cell Carcinoma

Approved in European Union as DermaSensor Device for:

• Melanoma
• Basal Cell Carcinoma
• Squamous Cell Carcinoma

Who Is Running the Clinical Trial?

DermaSensor, Inc.

Lead Sponsor

Trials

2

Recruited

1,400+

Published Research Related to This Trial

The Nevus Doctor (ND) clinical decision support system demonstrated a 100% sensitivity for detecting nonmelanoma skin cancer (NMSC) while maintaining a 95% sensitivity for melanoma, indicating its effectiveness for both types of skin lesions.

ND's specificity was lower at 12%, suggesting that while it is excellent at identifying NMSC without missing melanomas, it may produce a higher rate of false positives, highlighting areas for further improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Aided Decision Support for Melanoma Detection Applied on Melanocytic and Nonmelanocytic Skin Lesions: A Comparison of Two Systems Based on Automatic Analysis of Dermoscopic Images. Møllersen, K., Kirchesch, H., Zortea, M., et al.[2021]

Dermoscopy significantly improves the accuracy of detecting basal cell carcinoma (BCC) compared to visual inspection alone, with a relative diagnostic odds ratio of 8.2, indicating a 14% increase in sensitivity and a 22% increase in specificity.

The study analyzed 24 publications involving over 15,000 lesions, showing that while dermoscopy is effective for BCC diagnosis, there is insufficient data to evaluate its accuracy for cutaneous squamous cell carcinoma (cSCC).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual inspection and dermoscopy, alone or in combination, for diagnosing keratinocyte skin cancers in adults. Dinnes, J., Deeks, JJ., Chuchu, N., et al.[2022]

The study assessed 881 pigmented lesions from 860 patients using the SIAscope device and found that it did not significantly improve the ability of dermatologists to distinguish melanoma from nonmelanoma, with sensitivity remaining high but unchanged at 94%.

Despite the use of the SIAscope, the overall diagnostic performance (sensitivity and specificity) was similar to traditional clinical assessments, indicating that the device may not provide additional value in melanoma diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a spectrophotometric intracutaneous analysis device in the real-time diagnosis of melanoma in the setting of a melanoma screening clinic. Haniffa, MA., Lloyd, JJ., Lawrence, CM.[2019]

Dermoscopy significantly enhances the accuracy of skin cancer diagnosis by allowing clinicians to visualize subsurface skin structures, which helps in distinguishing malignant lesions like melanoma and basal cell carcinoma from benign ones.

The use of a two-step algorithm based on specific criteria improves the detection of skin cancers, guiding physicians on whether to perform a biopsy or reassure patients, thus optimizing patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermoscopy for the family physician. Marghoob, AA., Usatine, RP., Jaimes, N.[2014]

The Differential Optical Spectropolarimetric Imaging (DOSI) system shows promise as a non-invasive tool for diagnosing skin tumors, utilizing liquid crystal devices to analyze optical data from skin lesions.

While DOSI has demonstrated feasibility in research, it is not yet ready for clinical use, as reliable diagnostic indicators for specific skin tumors have not been established, although certain growth patterns may suggest malignancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Description of differential optical spectropolarimetric imaging system (DOSI) for non-invasive detection of skin tumors]. Arnon, O., Aharon, O., Silberstain, E., et al.[2012]

Dermoscopy is highly accurate for diagnosing both malignant and benign skin tumors, aiding in early detection and reducing unnecessary surgeries for benign lesions.

The effectiveness of dermoscopy relies on careful selection of skin lesions for examination, including not just large pigmented lesions but also smaller or changing lesions, and it is recommended to use descriptive terminology or algorithms for consistent diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dermoscopy for malignant and benign skin tumors : Indication and standardized terminology]. Blum, A., Kreusch, J., Stolz, W., et al.[2019]

In a study of 58 melanomas, in situ melanomas were found to be smaller and exhibited more nonspecific dermoscopic patterns compared to invasive melanomas, which showed more complex features.

Common dermoscopic criteria for identifying melanomas included asymmetry, multiple colors, and atypical networks, with invasive melanomas displaying a distinct inverted network pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermoscopic evaluation of superficial spreading melanoma. Trindade, FM., de Freitas, MLP., Bittencourt, FV.[2021]

In a study of 107 lesions evaluated by automated computer diagnosis systems, all three instruments correctly identified clinically obvious melanomas but struggled with accurately diagnosing suspicious melanocytic lesions, leading to significant variability in their diagnostic accuracy.

The systems tended to overdiagnose benign lesions, such as seborrhoeic keratoses, as potential malignancies, indicating that these computer-assisted diagnostic tools currently offer little added benefit for experienced dermatologists in distinguishing between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can automated dermoscopy image analysis instruments provide added benefit for the dermatologist? A study comparing the results of three systems. Perrinaud, A., Gaide, O., French, LE., et al.[2007]

Dermatoscopy is a noninvasive and effective technique for observing skin details that are not visible to the naked eye, enhancing the ability to diagnose skin conditions.

Handheld dermatoscopes are the most commonly used due to their user-friendliness and affordability, while videodermatoscopes offer higher magnification and better image management but at a higher cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermatoscopy: Instrumental Update. Micali, G., Lacarrubba, F.[2019]

Citations

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dermasensor.com/wp-content/uploads/80-0015.1-Clinical-Evidence-Three-Studies-1.pdf

Three Clinical Studies

Device sensitivity (95.5%) was found to be superior to that of study PCP investigators' (83.0%), p-value<0.0001. • Additionally, DermaSensor sensitivity was ...

2.

dermasensor.com

dermasensor.com/wp-content/uploads/Clinical-Evidence-Three-Studies.pdf

Clinical-Evidence-Three-Studies.pdf

The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or ... Detection of Skin Cancers.

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DermaSensor Increases Confidence and Accuracy in ...

Melanoma detection rates rose from 70.2% to 79.1%, reducing the rate of missed melanomas from 29.8% to 20.9%. Among participating clinicians, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12144386/

Primary Care Physician Use of Elastic Scattering ...

The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer adjunctive diagnostic device with high sensitivity and NPV.

5.

nature.com

nature.com/articles/s41746-024-01161-1

Learnings from the first AI-enabled skin cancer device for ...

Together, this article uses the DermaSensor authorization to examine the clinical evidence and regulatory implications of emerging AI-enabled ...

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DermaSensor: Advanced Skin Cancer & Melanoma Detection ...

96% sensitivity for detecting the three most common skin cancers² · Proprietary, FDA Cleared algorithm provides instant results · Enables objective referral ...

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accessdata.fda.gov

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DEN230008.pdf - accessdata.fda.gov

The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11180084/

Learnings from the first AI-enabled skin cancer device for ...

This article uses the DermaSensor authorization to examine the clinical evidence and regulatory implications of emerging AI-enabled technologies in dermatology.

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dermasensor.com

dermasensor.com/resource/dermasensor-unveils-study-results-demonstrating-ability-to-detect-skin-cancer-with-device-granted-fda-breakthrough-designation/

DermaSensor Unveils Study Results

A negative device result had a 98% chance of being negative for melanoma while a positive device result was melanoma approximately one out of ...