Presurgical Evaluation of Skin Cancers Using HIFU
Primary Purpose
Skin Cancer, Non-Melanoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
HIFU
Sponsored by
About this trial
This is an interventional supportive care trial for Skin Cancer, Non-Melanoma
Eligibility Criteria
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.
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with skin lesions
Arm Description
Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03457766
Brief Title
Presurgical Evaluation of Skin Cancers Using HIFU
Official Title
Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To ensure complete elimination of lesions with maximum preservation of function and aesthetics.
To elaborate the Ultrasonographic features of skin cancers.
To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Non-Melanoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Using high frequency ultrasound in identification of safety margins of skin cancers
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with skin lesions
Arm Type
Experimental
Arm Description
Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant
Intervention Type
Device
Intervention Name(s)
HIFU
Other Intervention Name(s)
Esaota MyLabSeven
Intervention Description
Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency
Primary Outcome Measure Information:
Title
Complete excision of nonmelanoma skin cancers
Description
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
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa AH El-Sonbaty, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
19043850
Citation
Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.
Results Reference
background
PubMed Identifier
24054424
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.
Results Reference
background
PubMed Identifier
20171403
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.
Results Reference
background
PubMed Identifier
22285673
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.
Results Reference
background
PubMed Identifier
18812268
Citation
Bobadilla F, Wortsman X, Munoz 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(1):163-72. doi: 10.1102/1470-7330.2008.0026.
Results Reference
background
PubMed Identifier
11966724
Citation
Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002 Apr;146 Suppl 61:1-6. doi: 10.1046/j.1365-2133.146.s61.2.x.
Results Reference
background
PubMed Identifier
16490846
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. doi: 10.1001/archderm.142.2.187.
Results Reference
background
PubMed Identifier
17101476
Citation
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.
Results Reference
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Presurgical Evaluation of Skin Cancers Using HIFU
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