Presurgical Evaluation of Skin Cancers Using HIFU

Skin Cancer, Non-Melanoma Clinical Trial

Official title:

Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457766
• Other study ID #: HIFU in skin cancers
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: June 13, 2022

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 13, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Cancer, Non-Melanoma
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Ansarin H, Daliri M, Soltani-Arabshahi R. Expression of p53 in aggressive and non-aggressive histologic variants of basal cell carcinoma. Eur J Dermatol. 2006 Sep-Oct;16(5):543-7. — View Citation

Bobadilla F, Wortsman X, Muñoz C, Segovia L, Espinoza M, Jemec GB. Pre-surgical high resolution ultrasound of facial basal cell carcinoma: correlation with histology. Cancer Imaging. 2008 Sep 22;8:163-72. doi: 10.1102/1470-7330.2008.0026. — View Citation

Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002 Apr;146 Suppl 61:1-6. Review. — View Citation

Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014 Mar 1;383(9919):816-27. doi: 10.1016/S0140-6736(13)60802-8. Epub 2013 Sep 19. Review. — View Citation

Essers BA, Dirksen CD, Nieman FH, Smeets NW, Krekels GA, Prins MH, Neumann HA. Cost-effectiveness of Mohs Micrographic Surgery vs Surgical Excision for Basal Cell Carcinoma of the Face. Arch Dermatol. 2006 Feb;142(2):187-94. — View Citation

Kleinerman R, Whang TB, Bard RL, Marmur ES. Ultrasound in dermatology: principles and applications. J Am Acad Dermatol. 2012 Sep;67(3):478-87. doi: 10.1016/j.jaad.2011.12.016. Epub 2012 Jan 30. Review. — View Citation

Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. 2010 Feb 20;375(9715):673-85. doi: 10.1016/S0140-6736(09)61196-X. — View Citation

Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete excision of nonmelanoma skin cancers	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