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Completed

NCT Number: NCT03457766

Presurgical Evaluation of Skin Cancers Using HIFU

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.

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Key information

Conditions

Skin Cancer, Non-Melanoma Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Egypt

About this study

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:

  • A morphologic study analyzing the structural sonographic pattern and margins;
  • the measurement of the largest transverse diameter and thickness;
  • Color Doppler USG for perilesional vessels ; and
  • in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIFU

Device

Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency

Other names: Esaota MyLabSeven

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2018
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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