Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Localized Renal Tumor

STATUS

Recruiting
End date

Dec 31, 2025
participants needed

40
sponsor

Zhen Wang, MD

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Updated on 19 February 2024

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cancer

MRI

estimated creatinine clearance

nephrectomy

kidney tumor

renal neoplasm

aggressiveness

abdominal mri

hyperpolarized carbon c 13 pyruvate

Summary

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This feasibility study will evaluate how well hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) scan works in predicting tumor aggressiveness in patients with localized renal tumor. Hyperpolarized 13C pyruvate is a non-radioactive substance with potential usage in the diagnostic imaging of tumors. Hyperpolarized 13C pyruvate MRI may help doctors determine non-invasively whether a kidney tumor is a benign tumor or cancer, and if cancer, how aggressive it is. This may help doctors and patients with renal tumors in the future to make better treatment decisions.

Description

PRIMARY OBJECTIVES:

To investigate the correlation between hyperpolarized (HP) 13C pyruvate-to-lactate conversion, as measured by lactate/pyruvate ratio, and renal tumor histology (benign renal tumors versus renal cell carcinomas (RCCs)) and grade (low versus high grade in cases of RCCs).
To investigate the correlation between HP 13C pyruvate-to-lactate conversion, as measured by 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:

To investigate the correlation between HP markers, as measured by lactate/pyruvate ratio, and tissue-based markers including Lactate dehydrogenase-A (LDHA) expression on tumor tissues from surgical specimen.
To investigate the correlation between HP markers, as measured by apparent rate constant kPL, and tissue-based markers including Lactate dehydrogenase-A (LDHA) expression on tumor tissues from surgical specimen.
To determine the safety of HP 13C pyruvate in renal tumor patients.

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 and undergo 13C pyruvate MRI scan 15 to 60 minutes following completion of the first scan.

After completion of study treatment, patients are followed up 30 minutes.

Details

Condition	Adenocarcinoma, Adenocarcinoma, urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Nephropathy, Renal Cell Carcinoma, Renal Cell Carcinoma, Benign Kidney Neoplasm
Age	18years - 100years
Treatment	Magnetic Resonance Imaging, Hyperpolarized Carbon C 13 Pyruvate
Clinical Study Identifier	NCT04258462
Sponsor	Zhen Wang, MD
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Localized renal tumor measuring 2 cm or greater in diameter
	The subject is either scheduled to undergo partial or radical nephrectomy at University of California San Francisco (UCSF), or has a diagnostic renal tumor biopsy indicating benign histology
	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
	Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)
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 contraindications to MRI, 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
	A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter will be allowed on study

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Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Localized Renal Tumor