Hyperpolarized 13C Pyruvate With or Without Hyperpolarized 13C, 15N Urea MRI Scan in Predicting Tumor Aggressiveness in Patients with Localized Renal Tumor

PRIMARY OBJECTIVE:

I. To investigate the association between hyperpolarized (HP) 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate/pyruvate AUC [area under the curve], the apparent rate constant kPL) and renal tumor histology (benign renal tumors versus renal cell carcinomas [RCCs]) and grade (low versus high grade in cases of RCCs).

SECONDARY OBJECTIVES:

I. To determine the reproducibility of HP 13C pyruvate magnetic resonance imaging (MRI) in patients who undergo an optional second HP 13C pyruvate MRI.

II. To investigate the association between HP 13C pyruvate-to-lactate conversion and tumor growth rate in patients who are deemed clinically appropriate for active surveillance for their renal tumors.

III. To determine the safety of HP 13C pyruvate in renal tumor patients.

EXPLORATORY OBJECTIVE:

I. To investigate the association between HP markers (peak lactate/pyruvate, lactate/pyruvate AUC, kPL, ADClac) and tissue-based markers including LDHA expression and LDH activity, and MCT4 expression on tumor tissues from surgical specimen.

II. To explore the correlation between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate/pyruvate AUC (area under the curve), the apparent rate constant kPL) and 13C urea tissue perfusion in the kidneys and renal tumors.

OUTLINE:

Patients receive HP 13C pyruvate intravenously (IV) and then undergo 13C MRI scan 1-2 minutes post HP 13C pyruvate injection. Patients may receive an optional second HP 13C pyruvate injection or hyperpolarized carbon 13C/nitrogen 15N urea (HP 13C 15N) injection and undergo 13C pyruvate MRI scan 15 to 30 minutes or 1-2 weeks following completion of the first scan. Patients who are scheduled to undergo active surveillance of their tumor may undergo 2 additional 13C MRI scans.

After completion of study treatment, patients are followed up at 30 minutes post-injection.