Advanced Diffusion Imaging in Renal Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve

Conditions
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Renal Cancer

Intervention / Treatment
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* Device: Magnetic Resonance Imaging (MRI) Scan
* Drug: Tc-99m Pentetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal mass patients scheduled for laparoscopic partial nephrectomy. eGFR above 30 ml/min/m2. Ages 21 to 85 Must be willing and able to provide consent. Exclusion Criteria: All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T. Pregnant women are not eligible for participating in this study. Acute claustrophobia

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Mass Patients<br>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. | Device: Magnetic Resonance Imaging (MRI) Scan<br>* Participants will undergo a 1-hour research MRI scan.<br>* Other names: Prisma 3T scanner;Drug: Tc-99m Pentetate<br>* Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery | Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type. | Baseline (1 Week Prior to Operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery | Results from the Renal Flow and Microstructure AnisotroPy-MRI (REFMAP-MRI) pre-surgical scan will be considered as predictors for either stability in renal function or incremental decline in renal function following surgery that would lead to chronic kidney disease (CKD), as defined by mGFR values and proteinuria status at follow-up. Post-surgical renal insult will be assessed based on either mGFR decline by over 2 ml/min/1.73 m2 per year or the appearance of proteinuria. | Up to Year 1 Post-Operation |