Dynamic Imaging of Variation in Lupus Nephritis

RILITE Foundation21 enrolled

Overview

To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI), blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow, perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus nephritis (LN) and compare these parameters to renal biopsy findings to determine whether DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal function and pathology in LN.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lupus Nephritis

Interventions

MRIPROCEDURE

This is a multicenter, non-interventional, pilot study. Eligible subjects will have a baseline MRI of the kidney, including anatomical, DWI, BOLD, T1rho, and DCE-MRI, utilizing a macrocyclic gadolinium-based contrast agent (GBCA), followed by planned standard of care (SOC) renal biopsy and clinical laboratory assessments. Additional serum and urine will be collected from subjects at baseline for analysis of research biomarkers. Following the results of the biopsy and clinical laboratory assessments, subjects will be treated for their underlying disease at the discretion of the investigator. At 6 months, subjects will return to the clinic for a second MRI, SOC clinical and laboratory evaluation and collection of serum and urine for analysis of research biomarkers.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provide written informed consent agreeing to all study procedures, before any study- specific procedures are done. 2. Male and female subjects 18 to 65 years of age, inclusive. 3. Subjects currently being evaluated for new or recurrent LN with a SOC kidney biopsy planned OR being evaluated for IgA nephropathy and with a SOC kidney biopsy planned. 4. Patients with LN must meet American College of Rheumatology (ACR) or Systemic Lupus Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE). 5. Subjects with a life expectancy \>6 months. Exclusion Criteria: 1. Participation in another investigational study during same time period. 2. Contraindication to receiving a GBCA. 3. More than 2 previous lifetime exposures to a GBCA. 4. Any contraindication to MRI, including metal implants, claustrophobia or morbid obesity. 5. Acute or chronic severe renal insufficiency (glomerular filtration rate \[GFR\] \<40 mL per minute per 1.73 m2). 6. Subject requiring dialysis. 7. Presence of pre-existing renal disease unrelated to SLE or IgA nephropathy, respectively. 8. Acute renal insufficiency of any severity caused by the hepato-renal syndrome. 9. Previous or pre-existing nephrogenic systemic fibrosis. 10. History of clinically significant anti-phospholipid syndrome. 11. Chronic liver function impairment, indicated by liver function tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]) \>2-fold upper limit of normal. 12. Platelet count \<50,000/μL. 13. Hemoglobin \<8.0 g/dL. 14. History of or presence of central nervous system (CNS) disease such as active lupus cerebritis or multiple sclerosis that might compromise blood brain barrier function. 15. Infection that is clinically relevant, particularly hepatitis B virus (HBV), hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV). 16. Pregnant or nursing females, or females not using effective contraception. 17. Inability or unwillingness to return to the research site clinic for study visits at baseline and at 6 months.

Locations (6)

The Regents of the University of Colorado

Aurora, Colorado, United States

New York University School of Medicine

New York, New York, United States

The Trustees of Columbia University in the City of New York

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Diffusion Weight Imaging

Diffusion weighted imaging (DWI) measures ADC values that quantify the combined effects of blood microcirculation and Brownian motion of water molecules within the interstitial space.

Time frame: 7 Months

Blood Oxygen Level Dependent Imaging

Blood oxygen level dependent (BOLD) imaging has been widely used to analyze blood flow in various 15 and is the preferred method to detect regional differences in blood flow.

Time frame: 7 Months

T1rho Imaging

T1rho (T1rho) imaging is an MRI technique that is sensitive to the presence of macromolecules, such as collagen and proteoglycan 13.

Time frame: 7 Months

Dynamic Contrast Enhanced Magnetic Resonance Imaging

Dynamic contrast enhanced (DCE) MRI (DCE-MRI) is an imaging method where T1-weighted MRI scans are acquired dynamically after injection of an MRI contrast agent (e.g., macrocylic gadolinium).

Time frame: 7 Months

Data from ClinicalTrials.gov

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