Advanced MRI Imaging for Kidney Cancer

Overseen By Nalini Jeet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Metal implants, Pregnancy, Claustrophobia

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

Compensation: Varies

Number of Visits: 2

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method using advanced MRI scans to better understand kidney tumors and their potential impact on kidney function over time. The researchers aim to determine if these scans can identify cancerous kidney masses and predict post-surgery kidney function. The trial may suit individuals preparing for kidney surgery with generally stable kidney function. Participants will undergo MRI and other kidney function tests over a few visits. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future kidney cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that advanced MRI imaging is safe for kidney cancer patients?

Research has shown that MRI scans are generally safe and well-tolerated for kidney evaluations. One study found that using MRI for kidney tumors results in acceptable side effects, even after five years. Another study suggests that advanced MRI methods can enhance understanding of kidney tumors without causing harm.

Tc-99m Pentetate, an FDA-approved imaging agent for kidney scans, helps doctors assess kidney function. Although it involves radiation, it is considered safe when used properly. Safety guidelines should always be followed to reduce exposure.

Both MRI and Tc-99m Pentetate are commonly used in medical imaging, with strong evidence supporting their safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to advance the way we assess kidney cancer using MRI technology. Unlike traditional imaging methods, which primarily rely on standard MRI sequences, this trial incorporates Advanced Diffusion Imaging sequences on a high-powered Prisma 3T MRI scanner. This could potentially offer more detailed insights into kidney tumors. Additionally, the use of a Tc-99m DTPA scan for assessing renal function is combined with these advanced imaging techniques, offering a comprehensive evaluation of the kidneys. This dual approach may enhance the accuracy of kidney cancer assessments, paving the way for better diagnosis and treatment strategies.

What evidence suggests that advanced MRI imaging is effective for assessing kidney cancer?

Research has shown that advanced MRI scans, which participants in this trial will undergo, can distinguish between different types of kidney tumors, crucial for treatment planning. Studies have found that MRI excels at identifying renal cell carcinoma, a type of kidney cancer, and can be more effective than other imaging methods. This capability aids doctors in making more accurate diagnoses.

Participants in this trial will also undergo Tc-99m Pentetate scans, a proven method for assessing kidney function. This scan is particularly useful after surgeries like partial nephrectomy, where part of the kidney is removed. Both MRI and Tc-99m Pentetate scans in this trial provide vital information for effectively managing kidney cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Eric Sigmund, PhD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 21 to 85 with kidney tumors who are scheduled for a type of surgery called laparoscopic partial nephrectomy. They must have a certain level of kidney function (eGFR above 30) and be able to consent. People with metal or dental implants unsafe in strong magnetic fields, pregnant women, or those with severe claustrophobia cannot join.

Inclusion Criteria

Must be willing and able to provide consent

I am scheduled for a partial kidney removal surgery.

My kidney function is above the minimum required level.

Exclusion Criteria

You are currently experiencing acute claustrophobia.

Pregnant women are not eligible for participating in this study

You have metal implants or dental implants that can't be used during an MRI scan at a strength of 3.0 Tesla.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Assessment

Participants undergo MRI and Tc-99m DTPA scans to characterize lesion malignancy and predict renal function stability or decline

1 week

2 visits (in-person)

Post-Surgery Follow-up

Participants are monitored for renal function stability or decline following partial nephrectomy

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging (MRI) Scan
• Tc-99m Pentetate

Trial Overview

The study uses advanced MRI scans and a tracer called Tc-99m Pentetate to assess the nature of kidney tumors and predict changes in kidney function after part of the kidney is surgically removed.

How Is the Trial Designed?

Group I: Renal Mass Patients Experimental Treatment 2 Interventions

Patients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan. In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Magnetic Resonance (MR) imaging is superior to other imaging methods for detecting and staging kidney tumors due to its high soft tissue contrast and ability to create images in multiple planes.

The development of improved breath-hold imaging techniques is expected to enhance the application of MR imaging for kidney tumors, making it an even more valuable tool in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging of renal neoplasms. Pretorius, ES., Wickstrom, ML., Siegelman, ES.[2005]

Rapid magnetic resonance imaging (MRI) with a paramagnetic contrast agent provides high-quality imaging of kidney lesions, matching the diagnostic capabilities of computed tomography (CT) for the first time in a study of 36 patients with renal cell carcinoma.

MRI demonstrated superior accuracy in assessing the T-stage of tumors and effectively showed venous invasion without needing a contrast medium, making it a valuable tool for planning surgical approaches, especially for organ-sparing procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical value of new rapid nuclear magnetic resonance tomography in preoperative assessment of hypernephroma. A prospective comparative study of CT and MR]. Vorreuther, R., Krestin, GP., Franzen, W., et al.[2015]

Gd-DTPA, a contrast agent used in MRI, has a very low incidence of adverse drug reactions (ADRs) at only 1.46% in a study of 13,439 patients, which is even lower than that of iodinated contrast media.

The safety profile of Gd-DTPA is favorable, showing good renal tolerance even in patients with pre-existing renal impairment, and fast bolus injections were well tolerated without additional risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerance data of Gd-DTPA: a review. Niendorf, HP., Dinger, JC., Haustein, J., et al.[2022]

Gadolinium diethylenetriaminepentaacetic acid (DTPA) significantly affects computed tomography (CT) imaging by causing substantial attenuation, particularly in concentrated forms.

In clinical cases, while Gd-DTPA showed high attenuation in the urinary bladder and renal collecting system, its concentration used in MR imaging only resulted in minor enhancement of the renal cortex, indicating limited impact on kidney imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gd-DTPA as a contrast agent in CT. Bloem, JL., Wondergem, J.[2015]

Magnetic Resonance (MR) imaging is valuable for detecting and staging renal cancers, especially when other imaging methods like CT or ultrasound are not suitable due to artifacts or patient conditions such as renal dysfunction or allergies to contrast media.

MR imaging is particularly effective in assessing complications of renal cancers, including inferior vena caval thrombus, lymph node involvement, liver metastases, direct organ invasion, and spinal bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection and staging of renal cancer. Choyke, PL.[2005]

Magnetic resonance imaging (MRI) can simultaneously assess both the structure and function of the kidneys, making it a valuable tool for evaluating renal conditions, especially when enhanced with fat suppression and contrast agents.

MRI is effective for staging renal cancers and differentiating between types of renal masses, serving as a reliable alternative to CT, particularly for patients who cannot use iodinated contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the kidneys: current status. Krestin, GP.[2004]

In a study of 79 patients with renal cell carcinoma, MRI demonstrated a slightly higher accuracy in predicting T-stage (84.0%) compared to CT (78.4%), making it a reliable imaging option for staging these tumors.

MRI showed advantages in detecting perirenal tumor spread and in ruling out infiltration beyond Gerota's fascia, positioning it as a valuable alternative to CT, especially for patients who cannot use iodinated contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The importance of magnetic resonance tomography in the diagnosis and staging of renal cell carcinoma]. Krestin, GP., Gross-Fengels, W., Marincek, B.[2006]

In a study of 33 renal carcinoma cases, both CT and MRI showed similar accuracy in staging early-stage tumors, correctly staging 27 and 28 tumors respectively.

For advanced renal carcinoma, MRI outperformed CT, particularly in accurately diagnosing tumor thrombus, suggesting that MRI could be a better alternative to conventional cavography for assessing tumor extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The staging of renal-cell carcinomas in MRT and CT--a prospective histologically controlled study]. Hallscheidt, P., Stolte, E., Roeren, T., et al.[2015]

MRI is an effective imaging tool for diagnosing and characterizing renal masses, providing both structural and functional insights, which is crucial for differentiating between conditions like renal cell carcinoma and benign tumors.

The advantages of MRI over CT include higher sensitivity for detecting contrast enhancement, no radiation exposure, and better characterization of renal cystic lesions, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-sectional imaging assessment of renal masses with emphasis on MRI. Tsili, AC., Moulopoulos, LA., Varakarakis, IM., et al.[2022]

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 involving New Zealand white rabbits with induced renal carcinoma, MRI using gadolinium-DTPA significantly enhanced tumor visibility, indicating its effectiveness in identifying viable tumor tissue.

The enhancement of tumors on T1 weighted images was immediate after gadolinium-DTPA injection and continued to increase for 30 minutes, demonstrating the potential of this imaging technique for monitoring tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-DTPA enhancement of VX-2 carcinoma of the rabbit kidney on T1 weighted magnetic resonance images. Yancey, JM., Ackerman, N., Kaude, JV., et al.[2015]

The study found that the signal intensity of MRI correlates linearly with Gd-DTPA concentration in the kidney, indicating that proper pulse sequences can optimize imaging quality, especially at low concentrations (0-2.0 mumol/g).

In patients receiving Gd-DTPA, the concentration in the renal cortex was measured to be between 0.132 to 0.152 mumol/g tissue, suggesting that Gd-DTPA is safely used in patients with varying renal function, including those with renal insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does gadolinium-diethylene triamine pentaacetic acid enhanced MRI of kidney represent tissue concentration of contrast media in the kidney? In vivo and in vitro study. Takeda, M., Katayama, Y., Tsutsui, T., 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]

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