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Advanced MRI Imaging for Kidney Cancer

N/A

Recruiting

Led By Eric Sigmund, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

eGFR above 30 ml/min/m2

Ages 21 to 85

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 1 post-operation

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging to assess if a kidney tumor is cancerous and how it may affect kidney function after surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

MRI scans are generally safe but can cause discomfort especially if you're claustrophobic. The tracer used may cause mild allergic reactions or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney function is above the minimum required level.

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I am between 21 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 1 post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 1 post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 1 post-operation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery

Secondary study objectives

Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery

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: Renal Mass PatientsExperimental Treatment2 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.

0 / 2Eligibility criteria met