Presurgical Evaluation of Skin Cancers Using HIFU

NCT ID: NCT03457766

Last Updated: 2022-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-06-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Skin Cancer, Non-Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Using high frequency ultrasound in identification of safety margins of skin cancers
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients with skin lesions

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

Group Type EXPERIMENTAL

HIFU

Intervention Type DEVICE

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

Interventions

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HIFU

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

Intervention Type DEVICE

Other Intervention Names

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Esaota MyLabSeven

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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George Gamil Gergis

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa AH El-Sonbaty, Professor

Role: STUDY_CHAIR

Assiut University

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 19043850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24054424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20171403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22285673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18812268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11966724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16490846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17101476 (View on PubMed)

Other Identifiers

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HIFU in skin cancers

Identifier Type: -

Identifier Source: org_study_id

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