Clinical Implementation of a Novel Ultrasound Technology for the Evaluation of Skin Lesions and Sentinel Lymph Node
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Pre and post treatment changes in lesions
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Ultrasound (Procedure)
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).
Intervention: Ultrasound (Procedure)
Cohort III (ultrasound)
Participants with inflammatory skin disorders (psoriasis, eczema, alopecia, acne) undergo ultrasound at baseline and follow-up visits.
Intervention: Ultrasound (Procedure)
Outcomes
Primary Outcomes
Pre and post treatment changes in lesions
Time Frame: 12 months from study start
Ultrasound findings will be reviewed for changes in lesions.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammad K. Khan
Principal Investigator
Emory University