MRI for Lupus

Overseen By Rebecca Krimins, DVM, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Renal dialysis, Renal transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to find out if a non-invasive Magnetic Resonance Imaging (MRI) examination of the kidneys may be helpful in patients with systemic lupus erythematosus (SLE).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Kidney MRI, Magnetic Resonance Imaging of the Kidneys, Renal MRI for lupus?

Research shows that advanced MRI techniques, like BOLD MRI, can help detect kidney issues in lupus patients without invasive procedures. These imaging methods are promising for diagnosing and monitoring kidney health in lupus nephritis, potentially leading to better treatment strategies. ^{1 2 3 4 5}

Is MRI safe for use in humans, particularly for kidney-related conditions?

MRI, including kidney MRI, is generally considered safe for humans as it is a noninvasive imaging technique used to diagnose and monitor various kidney conditions, including lupus nephritis and chronic kidney disease. ^{1 3 5 6 7}

How is the Kidney MRI treatment different from other treatments for lupus nephritis?

Kidney MRI is unique because it uses advanced imaging techniques to assess kidney damage in lupus nephritis without invasive procedures like biopsies. It provides detailed information on kidney function and disease progression, which can help in early diagnosis and better management of the condition. ^{1 2 4 5 8}

Research Team

Homa Timlin, MD, MSc, MRCP, CCST

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for individuals with systemic lupus erythematosus (SLE) who may have kidney inflammation known as lupus nephritis. Details on specific inclusion and exclusion criteria are not provided, but typically participants would need to meet certain health standards.

Inclusion Criteria

I am over 18, diagnosed with SLE, and can have a kidney MRI.

Exclusion Criteria

I have had a kidney transplant.

I am currently on kidney dialysis.

I do not have any conditions or devices that prevent me from having an MRI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Assessment

Participants undergo 1-4 kidney MRIs to evaluate inflammation, fibrosis, and atrophy

6 months

1-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI assessments

4 weeks

Treatment Details

Interventions

• Kidney MRI

Trial Overview The study is testing the use of non-invasive kidney MRI scans to diagnose lupus nephritis in SLE patients. Participants will undergo one or more MRI scans over six months to assess this diagnostic method.

Participant Groups

Group I: MRI Experimental Treatment 1 Intervention

A participant will undergo a MRI (1-4).

Kidney MRI is already approved in United States, European Union for the following indications:

Approved in United States as Kidney MRI for:

• Diagnostic tool for lupus nephritis in systemic lupus erythematosus (SLE) patients

Approved in European Union as Kidney MRI for:

• Diagnostic tool for lupus nephritis in systemic lupus erythematosus (SLE) patients

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Findings from Research

BOLD MRI is an effective non-invasive imaging technique that can help diagnose renal pathological patterns in patients with lupus nephritis, based on a study of 12 patients with various classifications of the disease.

The decision tree model developed from BOLD MRI data showed a sensitivity of 71.87% and an area under the ROC curve of 0.765, indicating it is a reliable method for distinguishing between different renal pathological patterns compared to other models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood oxygen level dependent magnetic resonance imaging for detecting pathological patterns in lupus nephritis patients: a preliminary study using a decision tree model. Shi, H., Jia, J., Li, D., et al.[2018]

Multiparametric magnetic resonance imaging (MRI) techniques, particularly magnetic resonance elastography (MRE), are effective in detecting nephropathy in patients with lupus nephritis (LN), showing better diagnostic performance than other imaging methods like BOLD imaging and diffusion-weighted imaging (DWI).

In patients with lupus nephritis, changes in the medulla tissue are detected first when renal function is still normal, and as the disease progresses, these changes extend to the inner cortex, indicating that MRE can help monitor disease progression effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tomoelastography Paired With T2* Magnetic Resonance Imaging Detects Lupus Nephritis With Normal Renal Function. Marticorena Garcia, SR., Grossmann, M., Bruns, A., et al.[2019]

A study involving 19 healthy subjects over 40 years old demonstrated that renal multiparametric MRI measurements have high repeatability, with coefficients of variation (CoVs) for most measurements below 13%, indicating reliability comparable to standard clinical tests in nephrology.

The most repeatable measurements were related to relaxometry and diffusion analyses, while perfusion measurements showed slightly higher variability, particularly for the perfusion fraction, suggesting that certain MRI techniques may be more consistent than others in assessing kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric Renal MRI: An Intrasubject Test-Retest Repeatability Study. de Boer, A., Harteveld, AA., Stemkens, B., et al.[2021]

In a study of 50 female participants, including 30 with lupus nephritis (LN), MRI findings showed that certain imaging metrics (FA and ADC) were decreased while R2* values were increased in LN patients compared to healthy controls, indicating potential changes in kidney tissue associated with the disease.

The study found significant correlations between MRI results and clinical indicators of disease severity, such as serum creatinine and SLEDAI scores, suggesting that MRI could be a valuable tool for assessing the severity and treatment outcomes of lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical study on the use of advanced magnetic resonance imaging in lupus nephritis. Chen, YX., Zhou, W., Ye, YQ., et al.[2022]

Lupus nephritis is a serious complication of systemic lupus erythematosus that can lead to significant kidney damage and poor health outcomes, making early diagnosis and assessment crucial.

Functional magnetic resonance imaging techniques are emerging as promising tools for better understanding and evaluating kidney function in lupus nephritis, potentially improving early diagnosis and monitoring of disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research progress in functional magnetic resonance imaging assessment of lupus nephritis kidney injury. Liu, S., Zhou, W.[2023]

In a study of 122 participants with chronic kidney disease (CKD), baseline apparent diffusion coefficient (ADC) values from kidney MRI were associated with changes in kidney function over time, indicating potential for MRI to help identify patients at risk for CKD progression.

However, this association was influenced by albuminuria, and overall, kidney MRI biomarkers remained stable over a 12-month period, suggesting they may not change significantly in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD. Srivastava, A., Cai, X., Lee, J., et al.[2023]

In a study involving 30 patients, renal magnetic resonance angiography significantly improved physicians' diagnostic certainty by 35%, indicating its effectiveness in enhancing diagnostic accuracy for suspected renovascular disease.

The results of MR angiography led to changes in initial diagnoses for 40% of patients and altered treatment plans for 67%, helping to avoid invasive procedures in 27% of cases, showcasing its impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of MR angiography on the diagnosis and treatment of patients with suspected renovascular disease. Omary, RA., Henseler, KP., Salem, R., et al.[2019]

In a pilot study involving 21 participants (6 with lupus nephritis, 8 with lupus non-nephritis, and 7 healthy volunteers), non-contrast MRI biomarkers showed significant correlations with standard renal function measurements, indicating their potential as reliable indicators of disease activity in lupus.

The study found that delayed blood flow and microstructural disruption in the kidneys of lupus nephritis patients were detectable through MRI, suggesting these imaging techniques could help assess kidney health without invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of non-contrast MRI biomarkers in lupus nephritis. Skeoch, S., Hubbard Cristinacce, PL., Dobbs, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Blood oxygen level dependent magnetic resonance imaging for detecting pathological patterns in lupus nephritis patients: a preliminary study using a decision tree model. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Tomoelastography Paired With T2* Magnetic Resonance Imaging Detects Lupus Nephritis With Normal Renal Function. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Multiparametric Renal MRI: An Intrasubject Test-Retest Repeatability Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical study on the use of advanced magnetic resonance imaging in lupus nephritis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Research progress in functional magnetic resonance imaging assessment of lupus nephritis kidney injury. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of MR angiography on the diagnosis and treatment of patients with suspected renovascular disease. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of non-contrast MRI biomarkers in lupus nephritis. [2022]