Trial record 8 of 1515 for:    Open Studies | "Autoimmune Diseases"

Microvascular and Fibrosis Imaging Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01758250
First received: December 26, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention
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 Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Microvascular density in oral mucosa and skin [ Time Frame: over 24 months ] [ Designated as safety issue: No ]
    Microvascular density as evaluated using LDF, LDI, OPSI, OCT, NVC and AFRI, will be compared between subjects with and without disease.

  • Microvascular Perfusion in oral mucosa and skin [ Time Frame: over 24 months ] [ Designated as safety issue: No ]
    Microvascular perfusion as evaluated using LDF, LDI, OPSI, OCT, NVC, and AFRI, will be compared between subjects with and without disease.


Estimated Enrollment: 220
Study Start Date: February 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758250

Contacts
Contact: Margaret (Peggy) Eren, RN 919-668-1047 eren0001@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Keith Sullivan, MD Duke University
Principal Investigator: Adela Cardones, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01758250     History of Changes
Other Study ID Numbers: Pro00039256
Study First Received: December 26, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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:
Autoimmune Diseases
Anemia, Sickle Cell
Fibrosis
Graft vs Host Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Immune System Diseases
Pathologic Processes
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014