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

NCT04258462 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 18525NCI-2018-03692R01CA249909
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will evaluate how well hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) scan works in predicting tumor aggressiveness in participants 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 participants with renal tumors in the future to make better treatment decisions.

Conditions

Benign Kidney Neoplasm; Kidney Neoplasm; Renal Cell Cancer

Outcome Measures

Primary Outcomes (3)

• Comparison between HP 13C pyruvate-to-lactate conversion, as measured by peak lactate/pyruvate ratio with tumor histology and grade.

  Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade renal cell carcinoma (RCC) vs. high grade RCCs based on the HP 13C pyruvate metabolic data

  Up to 12 months

• Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the lactate /pyruvate area under curve (AUC) with tumor histology and grade.

  Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. We will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;

  Up to 12 months

• Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the apparent rate of constant metabolic flux of HP 13C-pyruvate to lactate (kPL), with tumor histology and grade.

  Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;

  Up to 12 months

Secondary Outcomes (3)

• Estimate of intra-subject agreement for those with optional second scan

  Up to 12 months

• Comparison of the HP 13C metabolism measures to change in tumor size

  Up to 12 months

• Incidence of treatment-related adverse events

  1 day, 30 minutes following hyperpolarized 13C pyruvate injection

Study Arms (2)

Diagnostic (HP 13C pyruvate with MRI)

EXPERIMENTAL

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

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging

Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)

EXPERIMENTAL

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

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Drug: Hyperpolarized 13C,15N2-urea

Interventions

Hyperpolarized Carbon C 13 Pyruvate DRUG

Given IV

Also known as: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI); Diagnostic (HP 13C pyruvate with MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, Nuclear Magnetic Resonance Imaging

Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI); Diagnostic (HP 13C pyruvate with MRI)

Hyperpolarized 13C,15N2-urea DRUG

Given IV

Also known as: HP 13C, 15N2

Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, the investigators 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 participant is being considered by the treating physician to have any of the following management options: partial or radical nephrectomy, ablation, or active surveillance for his/her renal tumor.
• The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
• The participant 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.

You may not qualify if:

• Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• Participants 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.
• 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.

Sponsors & Collaborators

• Zhen Wang, MD: lead
• American Cancer Society, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Zhen Jane Wang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: February 6, 2020
• Study Start: January 15, 2019
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)