Clinical trial NCT01758250: Microvascular and Fibrosis Imaging Study
Official title: Mechanistic Study: Non-Invasive Cutaneous Microvascular and Fibrosis Imaging of Patients With Systemic Sclerosis, Sickle Cell Disease and Chronic Graft-Versus-Host Disease (GVHD) Compared to Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Sickle Cell Disease
Chronic Graft Versus Host Disease
Keywords: Autoimmune diseases with cutaneous involvement
Systemic sclerosis
Scleroderma
Morphea
Dermatomyositis
Cutaneous lupus
Vasculitis
Sickle Cell Disease
Graft versus Host Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population at Duke University Medical Center and healthy controls

Brief summary: In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical Coherence Tomography (OCT) will be used to assess differences in microvascular function and density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD) compared to healthy subjects. The microvascular changes will be compared to overall treatment response in patients with scleroderma and chronic GVHD as assessments will be made before and after the patients start treatment for their diseases and determine if these imaging techniques provide valuable and reproducible data when assessing a patient's response to treatment for those diseases. In addition, the application of Acoustic Radiation Force Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and morphea will be evaluated.

The investigators hypothesize that the vascular and dermal structures are altered in patients with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that imaging modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural alterations and can be used to 1) detect early disease activity, 2) quantify and assess response to therapy and 3) quantify and correlate with overall disease activity.


Eligibility criteria: Inclusion Criteria:

* Subjects above the age of 18 who are capable of giving informed consent with one of the following conditions: Scleroderma, Graft vs Host Disease, Sickle Cell Disease, Morphea, Connective Tissue Disease with cutaneous manifestations: cutaneous lupus, dermatomyositis, vasculitis, patients who are undergoing HSCT, or patients with a diagnosis of hematologic and non-hematologic malignancies without GVHD
* Control patients include normal healthy controls above the age of 18 who are capable of giving informed consent.

Exclusion Criteria:

* Patients who experience discomfort, will be prone to experience discomfort or cannot tolerate the position required for the imaging studies.
* Subjects unable to provide informed consent.
* Smokers, patients unable to tolerate caffeine avoidance for the day of the study.

Primary outcomes:
measure: Microvascular density in oral mucosa and skin
timeFrame: over 24 months
measure: Microvascular Perfusion in oral mucosa and skin
timeFrame: over 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Keith Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Adela Cardones, MD
role: PRINCIPAL_INVESTIGATOR
References: