Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Zhen Wang

Description

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.

Official Title

Hyperpolarized 13C Pyruvate Metabolic MRI to Predict Renal Tumor Aggressiveness

Details

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.

Keywords

Benign Kidney Neoplasm Kidney Neoplasm Renal Cell Cancer Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Aggression Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Imaging

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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
  2. 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.
  3. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
  4. The subject is willing to undergo standard of care abdominal MRI in connection with the study exam.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You CAN'T join if...

  1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
  2. 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.
  3. Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.
  4. 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.
  5. 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.
  6. Congestive heart failure or New York Heart Association (NYHA) status >= 2.
  7. 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.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94115 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zhen Wang, MD
ID
NCT04258462
Phase
Phase 2
Study Type
Interventional
Last Updated