Presurgical Evaluation of Skin Cancers Using HIFU
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|ClinicalTrials.gov Identifier: NCT03457766|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer, Non-Melanoma||Device: HIFU||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Using 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|
|Estimated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Patients with skin lesions
Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant
Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency
Other Name: Esaota MyLabSeven
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457766
|Contact: George G Gergis, Doctorate||+2 email@example.com|
|Contact: Ahmed MA Tohamy, Professor||+2 firstname.lastname@example.org|
|Study Chair:||Mostafa AH El-Sonbaty, Professor||Assiut University|