Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03914846 |
| Other study ID # |
IRB00086913 |
| Secondary ID |
NCI-2019-01754RA |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2019 |
| Est. completion date |
October 20, 2022 |
Study information
| Verified date |
January 2024 |
| Source |
Emory University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
