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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a non-invasive MRI scan of the kidneys (Kidney MRI) can benefit people with systemic lupus erythematosus (SLE), an autoimmune disease affecting various body parts. The researchers aim to determine if these scans offer useful information for managing kidney involvement in lupus. Participants will undergo one to four MRI scans. The trial seeks adults diagnosed with SLE who have not had a kidney transplant and are not on dialysis.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance kidney care for lupus patients.

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 prior data suggests that this MRI is safe for patients with lupus?

Research has shown that kidney MRI is generally safe. An MRI captures images of the body's interior without surgery or invasive tools, using magnets and radio waves. Studies have found that MRI, including kidney MRI, is usually well-tolerated, with few side effects or discomfort during the scan. Available studies report no serious problems linked to MRI. This method is widely used to diagnose and monitor various health conditions, indicating its high safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using kidney MRI for lupus because it offers a non-invasive way to monitor kidney health without needing a biopsy. Traditional methods for assessing lupus-related kidney issues often require invasive procedures like kidney biopsies, which can be uncomfortable and carry risks. MRI provides detailed images that could help doctors detect issues earlier and more accurately, potentially leading to better treatment outcomes. This approach could transform how doctors track kidney health in lupus patients, making it safer and less invasive.

What evidence suggests that a Kidney MRI is effective for systemic lupus erythematosus?

Research has shown that kidney MRI, which participants in this trial will undergo, can benefit people with lupus nephritis, a kidney problem caused by lupus. Studies have found that MRI can assess kidney damage without invasive procedures like biopsies. This imaging method helps doctors evaluate kidney appearance and function, aiding in treatment decisions. Early results suggest that MRI accurately reflects the kidney's health and damage level, making it a promising tool for monitoring kidney issues related to lupus. Overall, MRI provides a non-invasive way to track kidney health in lupus patients. ^{1 3 5 6 7}

Who Is on the Research Team?

Homa Timlin, MD, MSc, MRCP, CCST

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06445127

Evaluation of Patients With Lupus Nephritis Using Kidney ... 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 ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06445127

Evaluation of Patients With Lupus Nephritis Using Kidney MRI ... The primary objective of this research is to evaluate the best techniques for magnetic resonance imaging (MRI) of the kidneys in patients with lupus nephritis.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36451131/

Clinical study on the use of advanced magnetic resonance ... Objectives: To investigate the correlation between the histopathology of the kidney and clinical indicators in patients with lupus nephritis (LN) ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724070845

AB0534 DEVELOPMENT OF A MULTI-MODALITY ... This study will determine whether multi-modality imaging could become an effective, non-invasive tool to assess renal function and pathology in LN.

5. withpower.com withpower.com/trial/phase-nephritis-4-2024-3570e

MRI for Lupus · Info for Participants Kidney MRI is unique because it uses advanced imaging techniques to assess kidney damage in lupus nephritis without invasive procedures like biopsies.

6. bmcmedimaging.biomedcentral.com bmcmedimaging.biomedcentral.com/articles/10.1186/s12880-022-00928-w

Clinical study on the use of advanced magnetic resonance ... Objectives. To investigate the correlation between the histopathology of the kidney and clinical indicators in patients with lupus nephritis ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4536614/

Non-invasive imaging to monitor lupus nephritis and ... This paper reviews the challenges in evaluating disease activity in patients with LN and neuropsychiatric systemic lupus erythematosus (NPSLE).