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

Trial Summary

What is the purpose of this trial?

The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.

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 data supports the effectiveness of the treatment Advanced MRI Imaging for Kidney Cancer?

MRI is effective in diagnosing and staging kidney cancer, as it provides detailed images that help differentiate between cancerous and non-cancerous tumors, assess tumor spread, and monitor treatment progress without using radiation. ^{1 2 3 4 5}

Is MRI with Gd-DTPA safe for humans?

Gd-DTPA, a contrast agent used in MRI, has been tested in over 13,000 patients and is generally safe, with minor side effects occurring in about 1.46% of cases. It is well-tolerated even in patients with kidney issues, and no critical adverse reactions have been reported. ^{6 7 8 9 10}

How does the treatment in the Advanced MRI Imaging for Kidney Cancer trial differ from other treatments?

This treatment uses advanced MRI imaging, which provides detailed pictures of kidney tumors without radiation exposure, unlike CT scans. It offers better sensitivity for detecting tumor spread and can be used for patients who cannot tolerate traditional contrast agents. ^{1 3 11 12 13}

Research Team

Eric Sigmund, PhD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Cross-sectional imaging assessment of renal masses with emphasis on MRI. [2022]

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

[The staging of renal-cell carcinomas in MRT and CT--a prospective histologically controlled study]. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

[The importance of magnetic resonance tomography in the diagnosis and staging of renal cell carcinoma]. [2006]

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

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

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

Detection and staging of renal cancer. [2005]

6. Ireland pubmed.ncbi.nlm.nih.gov

Tolerance data of Gd-DTPA: a review. [2022]

7. Netherlands 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. [2019]

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

Gd-DTPA as a contrast agent in CT. [2015]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Gadolinium-DTPA enhancement of VX-2 carcinoma of the rabbit kidney on T1 weighted magnetic resonance images. [2015]

11. Germany 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]. [2015]

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

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

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

MR imaging of renal neoplasms. [2005]