Ultrasound in Diagnosing Patients With Skin Lesions

NCT03914846 | Completed

• 3 other identifiers: IRB00086913NCI-2019-01754RAD4512-18
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• Pre and post treatment changes in lesions

  Ultrasound findings will be reviewed for changes in lesions.

  12 months from study start

Study Arms (3)

Cohort I (ultrasound)

EXPERIMENTAL

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.

Procedure: Ultrasound

Cohort II (ultrasound)

EXPERIMENTAL

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).

Procedure: Ultrasound

Cohort III (ultrasound)

EXPERIMENTAL

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

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

Undergo ultrasound with elastography

Cohort I (ultrasound); Cohort II (ultrasound); Cohort III (ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mohammad K. Khan, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: April 29, 2019
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)