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Microvascular and Fibrosis Imaging Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01758250
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.


Condition or disease Intervention/treatment
Autoimmune Diseases Sickle Cell Disease Chronic Graft Versus Host Disease Other: Acoustic Radiation Force Impulse (ARFI) Other: Laser Doppler Flowmetry (LDF) Other: Laser Doppler Perfusion Imaging (LDI) Other: Optical Coherence Tomography (OCT) Other: Orthogonal Polarization Spectral Imaging (OPSI) Other: Nail fold video capillaroscopy (NVC)

Study Design
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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Systemic Sclerosis
Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
 Other: Acoustic Radiation Force Impulse (ARFI)
Other: Laser Doppler Flowmetry (LDF)
Other: Laser Doppler Perfusion Imaging (LDI)
Other: Optical Coherence Tomography (OCT)
Other: Orthogonal Polarization Spectral Imaging (OPSI)
Other: Nail fold video capillaroscopy (NVC)
GVHD
Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
 Other: Acoustic Radiation Force Impulse (ARFI)
Other: Laser Doppler Flowmetry (LDF)
Other: Laser Doppler Perfusion Imaging (LDI)
Other: Optical Coherence Tomography (OCT)
Other: Orthogonal Polarization Spectral Imaging (OPSI)
Other: Nail fold video capillaroscopy (NVC)
Undergoing HSCT
Patients who are about to undergo HSCT will have imaging studies performed at 1 week pre-transplantation, day 40 and 80 post transplantation and at 3 months, 6 months, 12 months 18 months and 24 months post-transplant.
 Other: Acoustic Radiation Force Impulse (ARFI)
Other: Laser Doppler Flowmetry (LDF)
Other: Laser Doppler Perfusion Imaging (LDI)
Other: Optical Coherence Tomography (OCT)
Other: Orthogonal Polarization Spectral Imaging (OPSI)
Other: Nail fold video capillaroscopy (NVC)
Controls
Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
 Other: Acoustic Radiation Force Impulse (ARFI)
Other: Laser Doppler Flowmetry (LDF)
Other: Laser Doppler Perfusion Imaging (LDI)
Other: Optical Coherence Tomography (OCT)
Other: Orthogonal Polarization Spectral Imaging (OPSI)
Other: Nail fold video capillaroscopy (NVC)
Sickle cell disease
Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
 Other: Acoustic Radiation Force Impulse (ARFI)
Other: Laser Doppler Flowmetry (LDF)
Other: Laser Doppler Perfusion Imaging (LDI)
Other: Optical Coherence Tomography (OCT)
Other: Orthogonal Polarization Spectral Imaging (OPSI)
Other: Nail fold video capillaroscopy (NVC)
Cutaneous fibrosing disorder
Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
 Other: Acoustic Radiation Force Impulse (ARFI)
Other: Laser Doppler Flowmetry (LDF)
Other: Laser Doppler Perfusion Imaging (LDI)
Other: Optical Coherence Tomography (OCT)
Other: Orthogonal Polarization Spectral Imaging (OPSI)
Other: Nail fold video capillaroscopy (NVC)


Outcome Measures
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Primary Outcome Measures :
  1. Microvascular density in oral mucosa and skin [ Time Frame: over 24 months ]
    Microvascular density as evaluated using LDF, LDI, OPSI, OCT, NVC and AFRI, will be compared between subjects with and without disease.

  2. Microvascular Perfusion in oral mucosa and skin [ Time Frame: over 24 months ]
    Microvascular perfusion as evaluated using LDF, LDI, OPSI, OCT, NVC, and AFRI, will be compared between subjects with and without disease.


Eligibility Criteria
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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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient population at Duke University Medical Center and healthy controls
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.
Contacts and Locations
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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): NCT01758250


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Keith Sullivan, MD Duke University
Principal Investigator: Adela Cardones, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01758250    
Other Study ID Numbers: Pro00039256
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: May 2020
Keywords provided by Duke University:
Autoimmune diseases with cutaneous involvement
Systemic sclerosis
Scleroderma
Morphea
Dermatomyositis
 Cutaneous lupus
Vasculitis
Sickle Cell Disease
Graft versus Host Disease
Additional relevant MeSH terms:
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Bronchiolitis Obliterans Syndrome
Anemia, Sickle Cell
Graft vs Host Disease
Autoimmune Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Immune System Diseases
Organizing Pneumonia
Bronchiolitis Obliterans
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases