Microvascular and Fibrosis Imaging Study

Completed

• Conditions: Autoimmune Diseases; Chronic Graft Versus Host Disease; Sickle Cell Disease
• Interventions: 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)

• Registration Number: NCT01758250
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-26
• Study First Submitted QC: 2012-12-26
• Study First Posted: 2013-01-01
• Study Start: 2013-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GVHD	Nail fold video capillaroscopy (NVC)	Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
Systemic Sclerosis	Laser Doppler Perfusion Imaging (LDI)	Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Systemic Sclerosis	Optical Coherence Tomography (OCT)	Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
GVHD	Optical Coherence Tomography (OCT)	Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
Systemic Sclerosis	Laser Doppler Flowmetry (LDF)	Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Systemic Sclerosis	Orthogonal Polarization Spectral Imaging (OPSI)	Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
GVHD	Acoustic Radiation Force Impulse (ARFI)	Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
GVHD	Laser Doppler Flowmetry (LDF)	Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
GVHD	Laser Doppler Perfusion Imaging (LDI)	Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
Systemic Sclerosis	Nail fold video capillaroscopy (NVC)	Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
GVHD	Orthogonal Polarization Spectral Imaging (OPSI)	Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
Controls	Nail fold video capillaroscopy (NVC)	Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Cutaneous fibrosing disorder	Laser Doppler Flowmetry (LDF)	Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
Systemic Sclerosis	Acoustic Radiation Force Impulse (ARFI)	Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Undergoing HSCT	Acoustic Radiation Force Impulse (ARFI)	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.
Undergoing HSCT	Laser Doppler Flowmetry (LDF)	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.
Undergoing HSCT	Laser Doppler Perfusion Imaging (LDI)	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.
Undergoing HSCT	Optical Coherence Tomography (OCT)	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.
Undergoing HSCT	Nail fold video capillaroscopy (NVC)	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.
Sickle cell disease	Acoustic Radiation Force Impulse (ARFI)	Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Controls	Acoustic Radiation Force Impulse (ARFI)	Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Controls	Orthogonal Polarization Spectral Imaging (OPSI)	Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Sickle cell disease	Orthogonal Polarization Spectral Imaging (OPSI)	Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Sickle cell disease	Nail fold video capillaroscopy (NVC)	Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Cutaneous fibrosing disorder	Laser Doppler Perfusion Imaging (LDI)	Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
Cutaneous fibrosing disorder	Orthogonal Polarization Spectral Imaging (OPSI)	Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
Undergoing HSCT	Orthogonal Polarization Spectral Imaging (OPSI)	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.
Controls	Laser Doppler Flowmetry (LDF)	Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Controls	Laser Doppler Perfusion Imaging (LDI)	Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Controls	Optical Coherence Tomography (OCT)	Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Sickle cell disease	Laser Doppler Flowmetry (LDF)	Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Sickle cell disease	Laser Doppler Perfusion Imaging (LDI)	Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Cutaneous fibrosing disorder	Nail fold video capillaroscopy (NVC)	Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
Sickle cell disease	Optical Coherence Tomography (OCT)	Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Cutaneous fibrosing disorder	Acoustic Radiation Force Impulse (ARFI)	Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
Cutaneous fibrosing disorder	Optical Coherence Tomography (OCT)	Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.

Primary Outcome Measures

Name	Time	Method
Microvascular density in oral mucosa and skin	over 24 months	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	over 24 months	Microvascular perfusion as evaluated using LDF, LDI, OPSI, OCT, NVC, and AFRI, will be compared between subjects with and without disease.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States