Viewing Study NCT03457766


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Study NCT ID: NCT03457766
Status: COMPLETED
Last Update Posted: 2022-11-25
First Post: 2018-02-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Presurgical Evaluation of Skin Cancers Using HIFU
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound
Status: COMPLETED
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: