Presurgical Evaluation of Skin Cancers Using HIFU

November 21, 2022 updated by: George Gamil Gergis, Assiut University

Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with skin lesions
Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant
Device: HIFU
Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency
Other Names:
  • Esaota MyLabSeven

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mostafa AH El-Sonbaty, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

May 15, 2022

Study Completion (ACTUAL)

June 13, 2022

Study Registration Dates

First Submitted

February 24, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (ACTUAL)

March 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU in skin cancers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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