Presurgical Evaluation of Skin Cancers Using HIFU

Not Applicable

Completed

• Conditions: Skin Cancer, Non-Melanoma
• Interventions: Device: HIFU

• Registration Number: NCT03457766
• Lead Sponsor: Assiut University

Brief Summary

1. To ensure complete elimination of lesions with maximum preservation of function and aesthetics.

2. To elaborate the Ultrasonographic features of skin cancers.

3. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..

4. To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.

Detailed Description

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:

1. A morphologic study analyzing the structural sonographic pattern and margins;

2. the measurement of the largest transverse diameter and thickness;

3. Color Doppler USG for perilesional vessels ; and

4. in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.

Study Timeline

• Study First Submitted: 2018-02-24
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-08
• Study Start: 2018-04-01
• Primary Completion: 2022-05-15
• Study Completion: 2022-06-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients between 30 & 80 years.
• Lesions clinically apparent locally malignant, or malignant.
• Lesions with or without visible ulcerations.

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Exclusion Criteria

• Surgeon unable to visualize tumor on clinical examination.
• Patients unfit for surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with skin lesions	HIFU	Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant

Primary Outcome Measures

Name	Time	Method
Complete excision of nonmelanoma skin cancers	Baseline	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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt