Evaluating the Performance of an AI-Based Dermoscopic Image Analysis System for Supporting Skin Tumor Diagnosis

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适应症

试验速览

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•Participants must meet all of the following criteria:
•If a patient has both benign and malignant tumors, the malignant tumor will be selected as the target lesion.
•(1) Patients who were photographed using the "Dermo Camera DZ-D100" (Notification Number: 06B2X10006000001) during routine clinical care to evaluate or differentiate skin tumors, and who have lesions that meet all of the following conditions:
•Lesions located on hair-bearing skin or acral sites suitable for dermoscopic examination
•Lesions with a maximum diameter of 4.0 mm to less than 25.0 mm
•Lesions in which ulceration, crusting, bleeding, or keratinization involve less than roughly 50% of the lesion area
•(2) Patients whose definitive diagnosis was made by a board-certified dermatologist of the Japanese Dermatological Association.
•(3) Patients whose definitive diagnosis is clearly documented in the medical record.
•For malignant tumors, a biopsy result is required.
•For benign tumors, biopsy results are also preferred when available.
•(4) Patients aged 18 years or older who have received sufficient explanation about the study and have provided written informed consent based on their free will and full understanding.
•If obtaining consent is not possible (e.g., due to relocation or death), the patient will be given an opportunity to decline participation through an opt-out process.

•Patients meeting any of the following criteria will be excluded from the study:
•(1) Patients with a history of skin tumors other than the dermoscopic lesion targeted for imaging and data collection in this study.
•(2) Patients whose dermoscopic lesion have undergone surgical procedures such as laser treatment or biopsy before dermoscopic imaging.
•(3) Patients with a dermoscopic lesion that is a recurrent or metastatic malignant skin tumor.
•(4) Patients with a dermoscopic lesion that meets any of the following image-related conditions:
•Non-polarized or UV images
•Poor image quality (e.g., insufficient lighting, blurry, or motion artifacts)
•Images taken using lens attachments or similar devices
•Images showing multiple lesions or diseases
•Images containing other skin abnormalities (e.g., trauma, tattoos, scars)
•Images contaminated with cosmetics (e.g., foundation), foreign objects (e.g., fibers, dust, rulers), or obvious dirt
•Images in which the lesion is significantly obscured (e.g., by body hair)
•Processed or edited images
•(5) Patients who already have another lesion registered in the study (only one lesion per patient will be collected).
•(6) Other patients deemed inappropriate for study registration by the responsible physician at the image-providing facility.

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