Scleroderma ARFI Imaging of the Skin

University of Michigan

Status: Completed

Conditions: Scleroderma

Treatments: Device: ARFI-SVI Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02006420

HUM00074229

Details and patient eligibility

About

Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening.

Currently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy.

The researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI).

The investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin.

This type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.

Full description

Scleroderma as well as numerous other rheumatologic conditions can affect the skin. Scleroderma in particular causes skin thickening and hardening.

Currently, evaluation of degree to which skin is affected by scleroderma is measured by a combination of a physical exam and skin biopsy results.

The investigators propose to measure skin hardness using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear wave velocity imaging (ARFI/SVI).

The investigators hypothesize that ARFI/SVI may be able to distinguish normal skin from skin affected by scleroderma (and other rheumatologic conditions). And, this ultrasound technique might measure the amount of fibrosis in the dermis (skin).

Such a radiologic biomarker could be used to help confirm the diagnosis of scleroderma. In addition, it may be usable for following patients over time and measuring their response to therapy and progression of disease.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)

Exclusion criteria

1. None

Trial design

45 participants in 2 patient groups

ARFI-SVI Ultrasound

Description:

Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.

Treatment:

Device: ARFI-SVI Ultrasound

Healthy Volunteers: ARFI/SVI Ultrasound

Description:

Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.

Treatment:

Device: ARFI-SVI Ultrasound