Ultrasound in Diagnosing Patients With Skin Lesions

NCT ID: NCT03914846

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2022-10-20

Brief Summary

This trial studies the use of a novel non-invasive ultrasound technique in diagnosing patents with skin lesions. Diagnostic procedures, such as ultrasound, may be a less invasive way to check skin lesions for skin cancer and other skin disorders.

Detailed Description

PRIMARY OBJECTIVES:

I. Characterize a wide variety of lesions including but limited to:

I a. Malignant lesions: basal cell cancers, squamous cell cancers, Merkel cell cancer, melanoma, etc.

I b. Non-malignant lesions: keloids, surgical scars, actinic keratosis, benign and dysplastic nevi, cysts, lipoma.

I c. Inflammatory conditions: psoriasis, eczema, alopecia, acne, wounds, etc). I d. Determine if ultrasound can be used to more effectively/accurately administer treatment (injections, surgical procedures, etc).

II. Characterize pre and post treatment changes in the lesion as well as the surrounding normal tissue stroma (examples, but not limited to: changes to hair follicles, epidermis, dermis, subcutaneous tissue, erector pillae muscles, vessels, nerves, etc).

III. Correlate ultrasonographic findings with histological findings for lesions that would have been removed surgically and/or are biopsied (examples, but not limited to: removal of a skin cancer where ultrasound is used to characterize peripheral extent of the lesion as well as depth of penetration, a benign versus malignant lesion, pigmented versus [vs] non-pigmented lesion, etc).

IV. Determine if ultrasound can be used to monitor acute and late toxicity. V. See if ultrasound can also image sentinel lymph nodes that may potentially contain cancer.

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT I: Patients with skin lesions undergo at least 1 ultrasound during the consultation. Patients may undergo at most 2 additional scans after the standard of care approach for non-malignant lesions at the discretion of the radiation oncologist and/or dermatologist.

COHORT II: Skin cancer patients who undergo surgery or radiation undergo 2-5 ultrasounds over a 1 year period (a baseline ultrasound scan may be performed prior to treatment, followed by 1 scan during and/or after radiation, and additional ultrasounds may be conducted [at the discretion of the treating physician] upon completion of radiation and/or surgery, at approximately 1, 6, and 12 month follow-up examinations).

COHORT III: Participants with inflammatory skin disorders (psoriasis, eczema, alopecia, acne) undergo ultrasound at baseline and follow-up visits.

Conditions

Skin Lesion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Cohort I (ultrasound)

Patients with skin lesions undergo at least 1 ultrasound during the consultation. Patients may undergo at most 2 additional scans after the standard of care approach for non-malignant lesions at the discretion of the radiation oncologist and/or dermatologist.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

Undergo ultrasound with elastography

Cohort II (ultrasound)

Skin cancer patients who undergo surgery or radiation undergo 2-5 ultrasounds over a 1 year period (a baseline ultrasound scan may be performed prior to treatment, followed by 1 scan during and/or after radiation, and additional ultrasounds may be conducted \[at the discretion of the treating physician\] upon completion of radiation and/or surgery, at approximately 1, 6, and 12 month follow-up examinations).

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

Undergo ultrasound with elastography

Cohort III (ultrasound)

Participants with inflammatory skin disorders (psoriasis, eczema, alopecia, acne) undergo ultrasound at baseline and follow-up visits.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

Undergo ultrasound with elastography

Interventions

Ultrasound

Undergo ultrasound with elastography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Candidate with skin lesions.
• Signed study-specific informed consent prior to study entry.

Exclusion Criteria

• Prior surgery or radiotherapy to the area to be treated.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad K. Khan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad K. Khan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

NCI-2019-01754

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD4512-18

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00086913

Identifier Type: -

Identifier Source: org_study_id