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Ultrasound in Diagnosing Patients With Skin Lesions

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03914846
Enrollment
47
Registered
2019-04-16
Start date
2019-04-29
Completion date
2022-10-20
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Lesion

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.

Interventions

PROCEDUREUltrasound

Undergo ultrasound with elastography

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pre and post treatment changes in lesions12 months from study startUltrasound findings will be reviewed for changes in lesions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026