Skip to main content
OpenTrials
Completed

NCT Number: NCT03914846

Ultrasound in Diagnosing Patients With Skin Lesions

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Procedure

Undergo ultrasound with elastography

Primary outcomes

  1. Pre and post treatment changes in lesions

    Time frame: 12 months from study start

    Ultrasound findings will be reviewed for changes in lesions.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Clinical Implementation of a Novel Ultrasound Technology for the Evaluation of Skin Lesions and Sentinel Lymph Node

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2019
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.