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Ultrasound in Diagnosing Patients With Skin Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914846
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammad K. Khan, Emory University

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.

Condition or disease Intervention/treatment Phase
Skin Lesion Procedure: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Implementation of a Novel Ultrasound Technology for the Evaluation of Skin Lesions and Sentinel Lymph Node
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: 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.
Procedure: Ultrasound
Undergo ultrasound with elastography

Experimental: 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).
Procedure: Ultrasound
Undergo ultrasound with elastography

Experimental: Cohort III (ultrasound)
Participants with inflammatory skin disorders (psoriasis, eczema, alopecia, acne) undergo ultrasound at baseline and follow-up visits.
Procedure: Ultrasound
Undergo ultrasound with elastography




Primary Outcome Measures :
  1. Pre and post treatment changes in lesions [ Time Frame: 12 months from study start ]
    Ultrasound findings will be reviewed for changes in lesions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914846


Contacts
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Contact: Mohammad K. Khan, MD, PhD 404-778-3473 m.k.khan@emory.edu
Contact: Suephy Chen, MD, MS 404-778-5225 schen2@emory.edu

Locations
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United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bridget Bradley, RN, FNP    404-778-3084    brbradl@emory.edu   
Contact: Giesla Rodgers    404-778-5162    grodg01@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Mohammad K. Khan, MD, PhD Emory University
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Responsible Party: Mohammad K. Khan, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03914846    
Other Study ID Numbers: IRB00086913
NCI-2019-01754 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD4512-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No