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

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for 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 data supports the effectiveness of the DermaSensor Device treatment for skin cancer detection?

Research shows that dermoscopy, a similar noninvasive imaging technique, improves the accuracy of skin cancer detection by allowing doctors to see skin structures not visible to the naked eye. This suggests that the DermaSensor Device, which likely uses similar technology, could also be effective in detecting skin cancer. ^{1 2 3 4 5}

How does the DermaSensor Device treatment for skin cancer detection differ from other treatments?

The DermaSensor Device is unique because it offers a non-invasive, relatively inexpensive method for detecting skin cancer by analyzing the skin's surface and depth, unlike traditional methods that rely heavily on clinical experience and expensive tools. It uses advanced technology to provide a quick and easy scan, making it more accessible for regular use compared to other non-invasive diagnostic tools. ^{4 6 7 8 9}

Research Team

Gary Slatko, MD, MBA

Principal Investigator

DermaSensor, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dermoscopy for the family physician. [2014]

2. United States 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. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

Dermoscopic evaluation of superficial spreading melanoma. [2021]

4. England 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Visual inspection and dermoscopy, alone or in combination, for diagnosing keratinocyte skin cancers in adults. [2022]

6. Israel pubmed.ncbi.nlm.nih.gov

[Description of differential optical spectropolarimetric imaging system (DOSI) for non-invasive detection of skin tumors]. [2012]

7. England 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. [2007]

8. Germany pubmed.ncbi.nlm.nih.gov

[Dermoscopy for malignant and benign skin tumors : Indication and standardized terminology]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Dermatoscopy: Instrumental Update. [2019]