Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors
Benign Kidney Neoplasm, Kidney Neoplasm, Renal Cell Cancer
About this trial
This is an interventional diagnostic trial for Benign Kidney Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, we have limited the lower size range of the tumor to 1 cm. The investigators will include all renal tumor measuring 1 cm and greater in diameter in this first study to facilitate obtaining tumors of a range of histology and grade
- The subject is either scheduled to undergo partial or radical nephrectomy at University of California, San Francisco (UCSF), or is deemed clinically appropriate to undergo active surveillance for his/her renal tumor. The subject is able and willing to comply with study procedures and provide signed and dated informed consent
- The subject is willing to undergo standard of care abdominal MRI in connection with the study exam.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Patients unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MR imaging, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.
- Prior focal therapy (i.e. ablation) for the renal tumor. In patients with tumor biopsy, imaging study will occur at least 4 weeks following any biopsy to avoid artifact from hemorrhage.
- Poorly controlled hypertension, with blood pressure at study entry >160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
- Congestive heart failure or New York Heart Association (NYHA) status >= 2.
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Diagnostic (HP 13C pyruvate with MRI)
Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)
Participants receive HP 13C pyruvate IV and then undergo 13C MRI scan 1-2 minutes post HP 13C pyruvate injection. Participants may receive an optional second HP 13C pyruvate injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI
Participants receive HP 13C pyruvate and 13C 15N2 urea IV and then undergo an MRI scan 1-2 minutes post injection. Participants may receive an optional second HP 13C pyruvate with 13C 15N2 urea injection and undergo a second MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI