NCT03457766

Brief Summary

  1. 1.To ensure complete elimination of lesions with maximum preservation of function and aesthetics.
  2. 2.To elaborate the Ultrasonographic features of skin cancers.
  3. 3.To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..
  4. 4.To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

4.1 years

First QC Date

February 24, 2018

Last Update Submit

November 21, 2022

Conditions

Skin Cancer, Non-Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with skin lesions

EXPERIMENTAL

Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant

Device: HIFU

Interventions

HIFUDEVICE

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

Also known as: Esaota MyLabSeven
Patients with skin lesions

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 30 \& 80 years.
  • Lesions clinically apparent locally malignant, or malignant.
  • Lesions with or without visible ulcerations.

You may not qualify if:

  • Surgeon unable to visualize tumor on clinical examination.
  • Patients unfit for surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 19043850BACKGROUND

  • 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.

    PMID: 24054424BACKGROUND

  • 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.

    PMID: 20171403BACKGROUND

  • 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.

    PMID: 22285673BACKGROUND

  • 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.

    PMID: 18812268BACKGROUND

  • 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.

    PMID: 11966724BACKGROUND

  • 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.

    PMID: 16490846BACKGROUND

  • 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.

    PMID: 17101476BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mostafa AH El-Sonbaty, Professor

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Using high frequency ultrasound in identification of safety margins of skin cancers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 24, 2018

First Posted

March 8, 2018

Study Start

April 1, 2018

Primary Completion

May 15, 2022

Study Completion

June 13, 2022

Last Updated

November 25, 2022

Record last verified: 2022-11

Locations

EG(1)