Presurgical Evaluation of Skin Cancers Using HIFU

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03457766
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Anticipated Duration (Months): 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Cancer, Non-Melanoma	Device: HIFU	N/A

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
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Using high frequency ultrasound in identification of safety margins of skin cancersUsing high frequency ultrasound in identification of safety margins of skin cancers
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound
• Anticipated Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Complete excision of nonmelanoma skin cancers [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002 Apr;146 Suppl 61:1-6. Review.
• 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.
• 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.
• 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.
• 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.
• Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. Review.

• Responsible Party: George Gamil Gergis, Doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT03457766
• Other Study ID Numbers: HIFU in skin cancers
• First Posted: Mar 8, 2018
• Last Update Posted: Mar 8, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Neoplasms

Study Results

No Results Posted as of Mar 8, 2018