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Clinical Trials/NCT03457766
NCT03457766
Completed
Not Applicable

Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound

Assiut University1 site in 1 country40 target enrollmentStarted: April 1, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Complete excision of nonmelanoma skin cancers

Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
30 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Complete excision of nonmelanoma skin cancers

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

George Gamil Gergis

Doctor

Assiut University

Study Sites (1)

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