MRI for Renal Fibrosis Detection

Recruiting in Palo Alto (17 mi)

Overseen by Lilach O Lerman, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must be taking: Antihypertensives

Must not be taking: Insulin, NSAIDs

Disqualifiers: Diabetes, HIV, Kidney transplant, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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, reproducible, and predicts recovery.

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 data supports the effectiveness of the treatment Quantitative Magnetization Transfer MRI for detecting renal fibrosis?

Research shows that Quantitative Magnetization Transfer MRI (qMT-MRI) can successfully detect renal fibrosis in swine kidneys with renal artery stenosis at clinical field strengths, and it is a reliable and reproducible method for distinguishing between fibrotic and normal kidneys. ^{1 2 3 4 5}

Is MRI using Quantitative Magnetization Transfer safe for humans?

MRI, including techniques like Quantitative Magnetization Transfer, is generally considered safe, but there are concerns about using gadolinium-based contrast agents in people with severe kidney problems, as they can cause a rare condition called nephrogenic systemic fibrosis (NSF). However, with proper guidelines, the risk of NSF is very low, especially in patients without severe kidney issues. ^{6 7 8 9 10}

How does MRI for Renal Fibrosis Detection differ from other treatments for renal fibrosis?

This treatment uses magnetization transfer imaging (MTI) with MRI to non-invasively detect renal fibrosis, which is different from the standard invasive method of renal biopsy. MTI is unique because it can provide detailed images of kidney tissue changes at different MRI field strengths, making it a promising tool for monitoring kidney health without surgery. ^{1 2 3 5 11}

Research Team

Lilach O Lerman, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• Quantitative Magnetization Transfer (MRI Technique)

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.

Participant Groups

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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]

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]

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]

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]

References

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

Reliable Assessment of Swine Renal Fibrosis Using Quantitative Magnetization Transfer Imaging. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Magnetisation transfer MR imaging of the kidney: evaluation at 3.0 T in association with renal function. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Imaging end-stage kidney disease in adults. Low-field MR imaging with magnetization transfer vs. ultrasonography. [2019]

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

Magnetization Transfer Imaging Is Unaffected by Decreases in Renal Perfusion in Swine. [2022]

5. Switzerland 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. [2023]

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

Molecular MRI of the Cardiovascular System in the Post-NSF Era. [2021]

7. United States 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. [2022]

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

Magnetic Resonance Safety in the 7T Environment. [2021]

9. United States 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. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance) in children. [2021]

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

Assessment of renal fibrosis in murine diabetic nephropathy using quantitative magnetization transfer MRI. [2020]