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Trial record 15 of 537 for:    "Skin cancer"

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
Sponsor:
Information provided by (Responsible Party):
George Gamil Gergis, Assiut University

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 Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

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 Name: Esaota MyLabSeven




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: George G Gergis, Doctorate +2 0100-099-8748 georgegamil.plastic@gmail.com
Contact: Ahmed MA Tohamy, Professor +2 0100-266-0832 ahmedtohamy92@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mostafa AH El-Sonbaty, Professor Assiut University

Publications:
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Responsible Party: George Gamil Gergis, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03457766     History of Changes
Other Study ID Numbers: HIFU in skin cancers
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases