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
Photo of Zhen Wang
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 renal tumors. 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 association between 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 RCCs) and grade (low vs 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 13 C pyruvate-to-lactate conversion and tumor growth rate in patients who are deemed clinically appropriate for active surveillance for their renal tumors. 3. To determine the safety of HP 13C pyruvate in renal tumor patients. EXPLORATORY OBJECTIVES: 1. To investigate the association between HP markers (peak lactate/pyruvate, lactate /pyruvate AUC, kPL) and tissue-based markers including Lactate Dehydrogenase A (LDHA) expression and lactate dehydrogenase (LDH) activity, and Monocarboxylate transporter 4 (MCT4) expression on tumor tissues from surgical specimen or from biopsy. 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. The investigators 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 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
  3. The subject is willing to undergo standard of care abdominal MRI in connection with the study exam.
  4. 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.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Zhen Wang
    Professor, Radiology. Authored (or co-authored) 132 research publications. Research interests: Hyperpolarized C13 for characterization of renal tumor and nephropathy · Imaging of pancreatic cancer · Oncological imaging · Molecular imaging.

Details

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