Skip to content

Presurgical Evaluation of Skin Cancers Using HIFU

Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03457766
Enrollment
40
Registered
2018-03-08
Start date
2018-04-01
Completion date
2022-06-13
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer, Non-Melanoma

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.

Interventions

DEVICEHIFU

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Using high frequency ultrasound in identification of safety margins of skin cancers

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Complete excision of nonmelanoma skin cancersBaselineDetermination 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026