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Perfusion MRI for Kidney Cancer

N/A

Waitlist Available

Led By Eric Singer, MD, MA

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test if female of child-bearing age

For patients with organ confined renal tumors to be enrolled, the renal mass must be >= 1 cm in diameter on computed tomography (CT) or magnetic resonance imaging (MRI) and can be any clinical stage T1a-T4 (non-metastatic); a histologic diagnosis is not required for enrollment; the primary imaging site would be kidney

Must not have

Women who are pregnant or breastfeeding

Severe renal function impairment (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m^2) would make the patient inappropriate for enrollment due to the increased risk of nephrogenic systemic fibrosis (NSF) with higher dose of IV gadolinium-based contrast agents (GBCA) administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses magnetic resonance imaging to help diagnose kidney tumors and predict how well patients will respond to treatment.

Who is the study for?

This trial is for adults with kidney tumors at least 1 cm in size, which can be non-metastatic or metastatic. Participants must understand and sign a consent form. Women of childbearing age need a negative pregnancy test. Those with severe diseases, poor kidney function (eGFR < 45), pregnant or breastfeeding women, and individuals unable to undergo MRI due to claustrophobia or metal implants are excluded.

What is being tested?

The study tests perfusion magnetic resonance imaging (MRI) techniques like Dynamic Susceptibility Contrast-Enhanced MRI and Arterial Spin Labeling MRI to diagnose kidney tumors and monitor treatment response. It's designed for patients who may have localized or spread cancer.

What are the potential side effects?

While the procedure itself is generally safe, potential side effects include discomfort from lying still during the scan, reactions to contrast agents such as nausea or itching, and very rarely nephrogenic systemic fibrosis in those with existing kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

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My kidney tumor is at least 1 cm big and hasn't spread, based on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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My kidney function is not severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perfusion MRI outputs

Progression free survival

Progression free survival and/or radiographic tumor evaluation

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (pMRI)Experimental Treatment4 Interventions

Patients undergo DCE, DSC, or ASL pMRI within 30 days of biopsy or surgery. Patients with organ confined tumors selected for active surveillance or surgery and patients with metastatic renal cell carcinoma undergo follow up pMRI at 1-6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perfusion Magnetic Resonance Imaging

2008

Completed Phase 2

~50

Arterial Spin Labeling Magnetic Resonance Imaging

2008

N/A

~40