Clinical trial NCT03457766: Presurgical Evaluation of Skin Cancers Using HIFU
Official title: Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer, Non-Melanoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using high frequency ultrasound in identification of safety margins of skin cancers
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete excision of nonmelanoma skin cancers
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Mostafa AH El-Sonbaty, Professor
role: STUDY_CHAIR
References:
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