MRI for Renal Fibrosis Detection

Overseen By Steph DiRenzo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Antihypertensives

Must not be taking: Insulin, NSAIDs

Disqualifiers: Diabetes, HIV, Kidney transplant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special MRI technique called quantitative magnetization transfer (qMT) to detect kidney fibrosis, a type of tissue damage. The goal is to determine if this MRI method can accurately predict recovery in individuals with kidney narrowing. The trial seeks participants who have had high blood pressure for over four weeks and are taking two or more medications for it. This opportunity may suit those managing hypertension who wish to contribute to research on kidney health. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance kidney health diagnostics.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking potentially harmful drugs to the kidneys, like certain pain relievers, you might not be eligible to participate.

What prior data suggests that this MRI technique is safe for detecting renal fibrosis?

Research has shown that Quantitative Magnetization Transfer (qMT) MRI is generally safe. This MRI type does not involve invasive procedures. Techniques like qMT are typically easy to tolerate and rarely cause discomfort. Although concerns exist about gadolinium-based contrast agents in MRIs, this issue does not specifically pertain to qMT. Overall, qMT MRI offers a noninvasive method to study kidney scarring, and studies indicate it effectively and reliably detects changes in the kidneys. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Quantitative Magnetization Transfer (qMT) for detecting renal fibrosis because it offers a non-invasive, imaging-based approach. Unlike standard methods that often rely on kidney biopsies, which can be invasive and carry risks, qMT aims to accurately quantify fibrosis through MRI technology. This technique could potentially allow for early identification and monitoring of fibrosis, providing a safer and more comfortable alternative for patients. By focusing on this innovative imaging method, researchers hope to improve the diagnosis and management of kidney conditions with greater precision and less risk.

What evidence suggests that this MRI technique is effective for detecting renal fibrosis?

Research has shown that a special type of MRI, called quantitative magnetization transfer (qMT), can effectively detect kidney scarring, known as fibrosis. In past studies, qMT proved to be a reliable and accurate method for measuring kidney damage, particularly fibrosis, which occurs when tissue becomes thickened or scarred. This MRI technique has been tested in animals and has outperformed other imaging methods in identifying fibrosis. In this trial, qMT will examine changes in the kidney's structure and function, aiding in the early detection of fibrosis. This approach provides a noninvasive way to assess kidney health and predict recovery outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Lilach O Lerman, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with high blood pressure needing multiple medications and normal kidney function (creatinine under specific levels). They must not have severe allergies to contrast agents, metal implants incompatible with MRI, claustrophobia, or conditions preventing protocol compliance. Excluded are those with recent serious medical events, uncontrolled hypertension, diabetes on medication, certain infections or drug requirements, heart issues, recent thrombosis, kidney transplant recipients or stones.

Inclusion Criteria

I am mentally capable of understanding and signing the consent form.

I have high blood pressure or take two or more blood pressure medications.

I am between 40 and 80 years old.

Exclusion Criteria

I have a single functioning kidney with reduced blood flow.

I am currently receiving treatment for an active cancer.

Patient has serum creatinine >2.2 mg/dL for men and >2.0 mg/dL for women (Caucasians); >2.4 mg/dL for men and >2.1 mg/dL for women (African American)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

A pilot study to test the ability of qMT to quantify fibrosis in the post-stenotic human kidney, in comparison to innovative biomarkers of renal dysfunction and tissue damage.

8 weeks

Evaluation

Evaluation of qMT in stenotic human kidneys to determine feasibility, reproducibility, and prediction of recovery.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the evaluation phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quantitative Magnetization Transfer

Trial Overview

The study tests if a special MRI technique called qMT can detect fibrosis in kidneys affected by narrowed arteries and predict recovery. It checks the method's feasibility and reliability in patients who meet specific health criteria.

How Is the Trial Designed?

Group I: Early identification of fibrosis. Experimental Treatment 1 Intervention

A pilot study to test the ability of qMT to quantify fibrosis in the post-stenotic human kidney, in comparison to innovative biomarkers of renal dysfunction and tissue damage. We will pursue the Specific Aim that qMT in stenotic human kidneys is feasible and reproducible.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Magnetization transfer (MT)-weighted MR imaging significantly improves the visibility of native kidneys in renal transplant patients compared to conventional T2-weighted images, enhancing the contrast between kidney remnants and surrounding fatty tissue.

While ultrasonography (US) is more effective for detecting small renal cysts due to its availability and cost-effectiveness, MT imaging can be a valuable alternative for selected patients needing better visualization of end-stage kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging end-stage kidney disease in adults. Low-field MR imaging with magnetization transfer vs. ultrasonography. Kajander, S., Kallio, T., Alanen, A., et al.[2019]

7T MRI technology introduces significant safety concerns, particularly due to stronger magnetic forces affecting magnetic objects and the interaction of high-frequency radio waves with body tissues.

To ensure patient safety and effective use of 7T MRI, a dedicated safety team is essential for developing policies, training staff, and managing the complexities of imaging, especially with implanted devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Safety in the 7T Environment. Fagan, AJ., Amrami, KK., Welker, KM., et al.[2021]

Two new molecular MRI agents have been approved for clinical use recently, and a third is in advanced clinical trials, indicating progress in the development of safer imaging options.

The review emphasizes the importance of prioritizing safety and efficacy in the design of molecular MRI agents, especially in light of past concerns like nephrogenic systemic fibrosis (NSF), which has seen no new cases reported since safety guidelines were implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular MRI of the Cardiovascular System in the Post-NSF Era. Sosnovik, DE., Caravan, P.[2021]

Quantitative magnetization transfer (qMT) successfully detected increased renal fibrosis in swine kidneys with unilateral renal artery stenosis (RAS) at a clinical field strength of 3.0 T, showing significant differences in the bound pool fraction between stenotic and normal kidneys.

The qMT measurements correlated strongly with histological assessments of fibrosis and inversely with renal perfusion, indicating its potential as a noninvasive tool for evaluating renal fibrosis in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliable Assessment of Swine Renal Fibrosis Using Quantitative Magnetization Transfer Imaging. Jiang, K., Ferguson, CM., Grimm, RC., et al.[2023]

Magnetisation transfer (MT) MRI at 3.0 T shows a strong correlation between the MT ratio (MTR) of the renal cortex and estimated glomerular filtration rate (eGFR), suggesting it can effectively assess renal function non-invasively.

Patients with decreased eGFR exhibited significantly higher MTR values in the renal cortex compared to those with normal renal function, indicating that this imaging technique may help identify renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetisation transfer MR imaging of the kidney: evaluation at 3.0 T in association with renal function. Ito, K., Hayashida, M., Izumitani, S., et al.[2021]

Magnetization transfer imaging (MTI) is a highly reproducible technique for detecting renal fibrosis in a porcine model, showing consistent results at both 1.5T and 3T MRI over time.

MTI successfully distinguished between normal and fibrotic kidneys, indicating its potential as a non-invasive method for assessing renal fibrosis in chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Renal Fibrosis Using Magnetization Transfer Imaging at 1.5T and 3T in a Porcine Model of Renal Artery Stenosis. Gandhi, DB., Al Saeedi, M., Krier, JD., et al.[2023]

Quantitative magnetization transfer MRI can effectively detect renal fibrosis in a murine model of diabetic nephropathy, showing significant increases in cortical pool size ratio (PSR) values compared to normal mice.

The study found that regions of abnormally high PSR correlated strongly with histological measures of fibrosis, suggesting that this MRI technique could serve as a novel imaging biomarker for assessing renal fibrosis in diabetic nephropathy and potentially other renal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of renal fibrosis in murine diabetic nephropathy using quantitative magnetization transfer MRI. Wang, F., Katagiri, D., Li, K., et al.[2020]

This review highlights the importance of considering the risks associated with contrast agents used in MRI and CT scans, particularly in patients with impaired kidney function.

It specifically compares nephrogenic systemic fibrosis and contrast-induced nephropathy, emphasizing the need to weigh the risks and benefits of each imaging modality when making diagnostic decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nephrogenic systemic fibrosis versus contrast-induced nephropathy: risks and benefits of contrast-enhanced MR and CT in renally impaired patients. Martin, DR., Semelka, RC., Chapman, A., et al.[2022]

In a study of 2053 patients with chronic kidney disease (CKD) who underwent gadolinium (Gd)-based MRI, no cases of nephrogenic systemic fibrosis (NSF) were reported during an average follow-up of 28.6 months, indicating that Gd-MRI is generally safe for CKD patients.

While Gd-MRI is safe for most CKD patients, caution is advised for those on dialysis and those with acute kidney injury, as well as for predialysis patients with stage 5 CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low risk for nephrogenic systemic fibrosis in nondialysis patients who have chronic kidney disease and are investigated with gadolinium-enhanced magnetic resonance imaging. Chrysochou, C., Power, A., Shurrab, AE., et al.[2022]

Multiparametric renal MRI, particularly magnetization transfer imaging (MTI), can reliably assess renal structural changes without being affected by hemodynamic changes during acute ischemia, as shown in a study with 7 domestic pigs.

While other MRI metrics like R2*, apparent diffusion coefficient (ADC), and stiffness showed significant changes during ischemia, MTI remained stable, indicating its potential as a noninvasive tool for evaluating renal fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetization Transfer Imaging Is Unaffected by Decreases in Renal Perfusion in Swine. Jiang, K., Ferguson, CM., Woollard, JR., et al.[2022]

A study involving 200 pediatric inpatients aged 4 days to 15 years found that gadobenate dimeglumine, a gadolinium-based contrast agent, did not result in any clinically adverse events within 24 hours after administration during contrast-enhanced MRI scans.

The safety evaluation showed no changes in kidney function (creatinine levels) or liver function (bilirubin levels) in the children, even among the youngest patients, indicating that gadobenate dimeglumine is safe for use in pediatric patients requiring multiple MRI examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance) in children. Schneider, G., Schürholz, H., Kirchin, MA., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7965778/

Quantitative Magnetization Transfer Detects Renal Fibrosis ...

This study demonstrates the feasibility of qMT at ultrahigh magnetic field strength of 16.4 T in mouse kidneys with unilateral RAS, and its superiority to MTR.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04508049

A Study to Evaluate Renal Fibrosis Using MRI Techniques | ...

The purpose of this study is to evaluate whether or not an MRI technique (quantitative magnetization transfer or qMT) in narrowing human kidneys is feasible, ...

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analyticalsciencejournals.onlinelibrary.wiley.com

analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/nbm.4128

Noninvasive quantitative magnetization transfer MRI reveals ...

While qMT MRI detected abnormally high PSR in OSOM (Figure 2), positive fibrosis areas were observed in the histological results (Figure 7). The ...

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mdpi.com

mdpi.com/2077-0383/12/8/2956

Evaluation of Renal Fibrosis Using Magnetization Transfer ...

Magnetization transfer imaging (MTI) allows estimates of renal fibrosis but may vary with scanning conditions. We hypothesized that MTI-derived ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1931524419300416

Noninvasive assessment of renal fibrosis by magnetic ...

These imaging techniques measure renal fibrosis by evaluating its impacts on the functional, mechanical, and molecular properties of the kidney.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10140905/

Evaluation of Renal Fibrosis Using Magnetization Transfer ...

MTI is a highly reproducible technique which is sensitive to detect changes in fibrotic compared to normal kidneys in the RAS porcine model at 3T.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6817372/

Noninvasive Quantitative Magnetization Transfer MRI ...

Renal tubulointerstitial fibrosis in OSOM can thus be assessed by qMT MRI using an appropriate analysis of PSR. This technique may be used as an ...

8.

withpower.com

withpower.com/trial/phase-fibrosis-9-2020-507fb

MRI for Renal Fibrosis Detection · Info for Participants

MRI, including techniques like Quantitative Magnetization Transfer, is generally considered safe, but there are concerns about using gadolinium-based ...

9.

mayo.edu

mayo.edu/research/clinical-trials/cls-20507606

Quantitative Magnetization Transfer MRI for Evaluation of ...

The purpose of this study is to evaluate whether or not an MRI technique (quantitiative magnetization transfer or qMT) in narrowing human ...