Presurgical Evaluation of Skin Cancers Using HIFU

Study Overview
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Brief Summary
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To ensure complete elimination of lesions with maximum preservation of function and aesthetics. To elaborate the Ultrasonographic features of skin cancers. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination.. To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.

Detailed Description
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The skin is the most superficial and largest body organ, due to its function as a surface covering for the body, enables the performance of noninvasive diagnostic and investigative procedures. Of all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Techniques such as high frequency ultrasound (HFUS) enable the real-time study of cutaneous lesions, making them excellent pre-operative tools varying considerably in their penetration, resolution, and applicability. High frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a painless non-radioactive imaging diagnostic method based on the reflection of sound waves through body tissues. High frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic perilesional area. High frequency ultrasound examination of each lesion should consist of: A morphologic study analyzing the structural sonographic pattern and margins; the measurement of the largest transverse diameter and thickness; Color Doppler USG for perilesional vessels ; and in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.

Official Title
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Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound

Conditions
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Skin Cancer, Non-Melanoma

Intervention / Treatment
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* Device: HIFU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 30 & 80 years. Lesions clinically apparent locally malignant, or malignant. Lesions with or without visible ulcerations. Exclusion Criteria: Surgeon unable to visualize tumor on clinical examination. Patients unfit for surgery.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Using high frequency ultrasound in identification of safety margins of skin cancers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with skin lesions<br>Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant | Device: HIFU<br>* Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency<br>* Other names: Esaota MyLabSeven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete excision of nonmelanoma skin cancers | Determination the accuracy of HIFU to assess the margins of skin lesions and its safety margins to ensure complete elimination of lesions with maximum preservation of function and aesthetics | Baseline |