Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors

PRIMARY OBJECTIVES:

I. To investigate the utility of perfusion magnetic resonance imaging (pMRI) as a diagnostic
biomarker for the prediction of malignant vs. benign organ confined renal masses.

II. To investigate the utility of pMRI as a therapeutic biomarker for monitoring tumor
progression in patients undergoing treatment (ablation, surgery, specific systemic treatments
such as interleukin 2 (IL-2) or vascular endothelial growth factor [VEGF]/vascular
endothelial growth factor receptor [VEGFR]/mechanistic target of rapamycin [mTOR] targeted
therapies) or active surveillance for organ confined or metastatic renal tumors.

SECONDARY OBJECTIVES:

I. To investigate the utility of pMRI to predict tumor grade and histologic subtype of organ
confined kidney cancers.

OUTLINE:

Patients undergo dynamic contrast enhanced (DCE), dynamic susceptibility contrast (DSC), or
arterial spin labeled (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.

After completion of study, patients are followed up within 48 hours.

Inclusion Criteria:

- Patients must be able to read, understand, and voluntarily sign an informed consent
document

- 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

- For patients with metastatic renal tumors to be enrolled, a histologic diagnosis of
renal cell carcinoma must exist and any burden of disease >= 1 cm by CT or MRI is
acceptable; the metastatic sites may be kidney, intra-abdominal (such as liver),
brain, bone, or lymph nodes; lung lesions are NOT eligible because of the motion
artifact caused by respiration

- Patients with metastatic disease may have received prior nephrectomy and/or prior
systemic therapy (no limit on number); their baseline pMRI would be performed prior to
starting a new treatment

- Negative pregnancy test if female of child-bearing age

- Able to undergo contrast enhanced MRI

Exclusion Criteria:

- Severe concurrent disease, infection, or medical co-morbidity that, in the judgment of
the investigator, would make the patient inappropriate for enrollment

- 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

- Women who are pregnant or breastfeeding

- Subjects who are unable to tolerate or are not eligible for MR imaging
(claustrophobia, metal implantable devices such as pacemaker, aneurysm clips, etc)

- Subjects with established allergy to IV GBCA