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Diagnostic Imaging Agent

Hyperpolarized 13C Pyruvate MRI for Kidney Cancer

Phase 2
Recruiting
Led By Zhen Jane Wang, MD
Research Sponsored by Zhen Wang, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal tumor measuring 1 cm and greater in diameter
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial will see if a non-radioactive substance called hyperpolarized 13C pyruvate can help doctors predict how aggressive a kidney tumor is. If successful, this could help patients and doctors make better treatment decisions in the future.

Who is the study for?
This trial is for adults with kidney tumors larger than 1 cm who can follow study procedures and give informed consent. They should be fit enough for potential kidney surgery or active monitoring, with a good performance status (able to carry out daily activities). People with metal implants affecting MRI quality, heart failure, uncontrolled high blood pressure, or those unable to undergo MRI are excluded.Check my eligibility
What is being tested?
The study tests if a special type of MRI scan using hyperpolarized 13C pyruvate can predict how aggressive kidney tumors are without invasive procedures. This non-radioactive imaging technique could help doctors and patients choose the best treatment by distinguishing between benign and cancerous tumors.See study design
What are the potential side effects?
Since hyperpolarized 13C pyruvate is used for diagnostic imaging rather than treatment, side effects may be minimal compared to therapeutic drugs. However, typical MRI-related discomforts such as loud noises during scanning or claustrophobia might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney tumor is at least 1 cm big.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neoplasms
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.
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the lactate /pyruvate area under curve (AUC) with tumor histology and grade.
Secondary outcome measures
Comparison of the HP 13C metabolism measures to change in tumor size
Estimate of intra-subject agreement for those with optional second scan
Incidence of treatment-related adverse events

Side effects data

From 2019 Phase 1 trial • 9 Patients • NCT03565367
33%
Anosmia
33%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteers
Known CNS Malignancy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Diagnostic (HP 13C pyruvate with MRI)Experimental Treatment2 Interventions
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
Group II: Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)Experimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Hyperpolarized Carbon C 13 Pyruvate
2018
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Zhen Wang, MDLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,355 Total Patients Enrolled
Zhen Jane Wang, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Hyperpolarized 13C Pyruvate (Diagnostic Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04258462 — Phase 2
Kidney Cancer Research Study Groups: Diagnostic (HP 13C pyruvate with MRI), Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)
Kidney Cancer Clinical Trial 2023: Hyperpolarized 13C Pyruvate Highlights & Side Effects. Trial Name: NCT04258462 — Phase 2
Hyperpolarized 13C Pyruvate (Diagnostic Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258462 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this clinical exploration?

"Yes, clinicaltrials.gov confirms that this medical experiment is searching for candidates, with the original posting date of January 15th 2019 and an edit as recent as July 21st 2022. 100 individuals are required to be enlisted across a single facility."

Answered by AI

What is the primary aim of this research endeavor?

"This trial's primary outcome, measured over a duration of 12 months, is to analyse the contrast between HP 13C pyruvate-to-lactate conversion (as quantified by AUC) and tumor grade. Secondary objectives involve correlating HP MR lactate/pyruvate AUC with LDH activity using Spearman's rank correlation coefficient or Mann–Whitney U test; connecting HP MR kPL with LDHA expression in like manner; and comparing the peak lactate/pyruvate from this scan with Lactase dehydrogenase activity through either method."

Answered by AI

Is the utilization of Hyperpolarized Carbon C 13 Pyruvate sanctioned by the FDA?

"Hyperpolarized Carbon C 13 Pyruvate's safety is only partially confirmed by clinical data, which resulted in a rating of 2. This drug has not yet passed Phase 3 trials and there is no evidence to support its efficacy."

Answered by AI

Is enrollment in this experimental research still available?

"Based on the information provided by clinicaltrials.gov, this medical trial is currently seeking volunteers; its initial launch date was January 15th 2019 and it has been amended most recently on July 21st 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors
Zhen Wang, MD 2019. "Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258462.
~34 spots leftby Dec 2026
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