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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    100
  • sponsor
    Zhen Wang, MD
Updated on 27 January 2021
estimated creatinine clearance
cancer
MRI
kidney tumor
nephrectomy
renal neoplasm
hyperpolarized carbon c 13 pyruvate

Summary

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:

  1. 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).
  2. 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:

  1. To determine the reproducibility of HP 13C pyruvate MRI in patients who undergo an optional second HP 13C pyruvate MRI.
  2. 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 Monocarboxylate transporter 4 (MCT4) expression on tumor tissues from surgical specimen or from biopsy.
  3. 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, urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Renal Cell Carcinoma, Kidney Disease (Pediatric), Kidney Cancer, Malignant Adenoma, Kidney Disease, Renal Cell Cancer, Renal Cancer, Urologic Cancer, Benign Kidney Neoplasm, kidney neoplasm, cancer, renal, kidney tumor, renal tumors, neoplasia renal, renal neoplasm, renal tumor, kidney tumours, kidney tumors
Treatment magnetic resonance imaging, Hyperpolarized Carbon C 13 Pyruvate
Clinical Study IdentifierNCT04258462
SponsorZhen Wang, MD
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Localized renal tumor measuring 2 centimeters (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 2cm. We will include all localized renal tumor measuring 2 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 has a diagnostic renal tumor biopsy indicating benign histology. An increasing number of patients with small renal tumors at UCSF are referred for renal tumor biopsy and then active surveillance especially if biopsy indicates high likelihood of benign histology. We will recruit these patients into our study to ensure adequate number of benign renal tumors for this initial pilot study
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
A history of clinically significant electrocardiogram (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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